Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures

Cement augmentation of humeral head screws reduces early implant-related complications after... Original Contribution 1,2 1 1 1 1 Obere Extremität 2018 · 13:123–129 J. Christoph Katthagen ·O.Lutz ·C.Voigt ·H.Lill ·A.Ellwein https://doi.org/10.1007/s11678-018-0440-x Department of Orthopaedic and Trauma Surgery, DIAKOVERE Friederikenstift, Hannover, Germany Received: 11 October 2017 Department of Trauma, Hand and Reconstructive Surgery, Universitätsklinikum Münster, Münster, Accepted: 5 January 2018 Germany Published online: 30 January 2018 © The Author(s) 2018. This article is an open access publication. Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures Humeral head screw augmentation LOS plate (DePuy Synthes ,Umkirch, Introduction with polymethyl methacrylate (PMMA) Germany) along with additional humeral Locked plating of displaced proximal trauma cement has been shown to en- head screw augmentation with PMMA humeral fractures (PHF) poses a se- hance screw anchorage and to thereby trauma cement in this prospective case rious challenge to orthopedic trauma increase the primary stability of locked series. The study was approved by the surgeons. The biologic circumstances plating of displaced PHF in several institutional review board and informed of the mainly older patient population biomechanical studies [11–14]. The pri- consent was obtained from all individ- with osteoporotic bone stock make screw mary goal of this study was to evaluate ual participants included in the study. anchorage difficult [1–3]. The unique whether these in vitro findings can be Inclusion criteria were: mechanical setting with the humeral translated into daily clinical routine with- 1. Displaced unilateral PHF head articulating surface being loaded out additional complications compared 2. Age of at least 18 years against the screw tips and the rotator with conventional locked plating without 3. Written informed consent cuff pulling in an antero- and postero- additional trauma cement augmentation. medial direction demands for a fracture The secondary goal was to compare func- Patients were excluded from the study if fixation with immediate stability [4, 5]. tional outcomes and complication rates they: However, the ideal implant characteris- between locked plating of PHF with 4. Had a bilateral PHF and/or tics should make the construct flexible cement augmentation versus without 5. Had previous shoulder surgery or enough to unload the bone implant in- cement augmentation of humeral head a neurologic disease with impairment terface but rigid enough to minimize screws. We hypothesized that locked of the upper extremity and/or fracture movements [6]. plating of PHF with additional cement 6. Refused to participate Despite identification of several po- augmentation of humeral head screws tential risk factors for fixation failure can be used in clinical practice without Preoperative patient-specific data such and regardless of the continuous devel- additional complications and that early as age, gender, affected side, preexisting opment of implants with improved plate implant-related complications can be diseases and medications, as well as con- and screw design, the complication rate reduced compared with locked plating comitant fractures were noted. The PHF associated with locked plating of PHF is without additional cement augmentation were preoperatively classified according still high [2, 7, 8]. Especially in fragility of humeral head screws. the Codmansegmenttheoryand the clas- fractures of the older population, loss of sification suggested by Resch et al. [15, reduction with secondary articular screw 16]. The neck–shaft angle (NSA) was Methods perforation and varus displacement with measured on a standardized true antero- loss of fixation can still be observed in up Between February 2014 and Septem- posterior (AP) view on the second day af- to 20% of cases within the first 12 months ber 2015, 39 patients underwent fracture ter surgery [17]. X-rays were further an- postoperatively [9, 10]. fixation of a displaced PHF with the PHI- alyzed for primary screw perforation, for Obere Extremität 2 · 2018 123 Original Contribution age pain measured with the Visual Ana- log Scale (VAS) of the affected shoulder were assessed. Furthermore, all compli- cations and reoperations were evaluated and noted. Patients with conventional titanium locked plating A case-control cohort of 24 patients (two male, 22 female; mean age, 73.9 ± 9.4 years) treated with a conventional titanium locking plate was used to com- pare the Constant score and the com- plication rates with the results of the patients treated with additional cement augmentation of humeral head screws. These 24 patients derived from a historic retrospective cohort of 74 patients (54 fe- Fig. 1 8 Preoperative radiographs of an 87-year-old female patient with valgus-displaced three-part males, 20 males; mean age, 73 years) proximal humeral fracture (a anteroposterior, bYview) treated with the PHILOS PHF plate. The best match with regard to gender, age, displaced fragments, and for the quality of motion was allowed immediately af- affected side, and fracture complexity ac- of reduction according to Marc Schnet- ter surgery without weight-bearing for cordingtoCodman’ssegmenttheorywas zke et al. [8, 18]. Failure was defined 6 weeks. sought. The investigator who matched as a “malreduced” situation according to 24 patients of the historic PHILOS group Schnetzke et al. [8]. without additional cement augmenta- Functional and radiological tion was blinded to functional outcomes, follow-up complications, and reoperations. Apart Titanium plating with cement Patients were followed up clinically and from cement augmentation of humeral augmentation of humeral head radiologically at 3 months postopera- head screws, the operative technique and screws tively and again clinically at 12 months the postoperative rehabilitation protocol The PHILOS plate (DePuy Synthes )is postoperatively. At the 3-month follow- were identical to those of patients with made of titanium alloy. The shaft was up, patients had radiographs in two locked plating and additional cement fixed with three 3.5-mm screws in all planes (true AP and axial) unless pre- augmentation. cases. The number of 3.5-mm humeral vious radiographs had demonstrated head screws used ranged from 5 to 9 fracture consolidation. The NSA was Statistical analysis (on average, 7). An average of three measured again [17]. Furthermore, both cannulated humeral head screws (range, radiographic planes were evaluated for: All data was analyzed by means of de- 2–5) were augmented with 0.5–1 ml of 1. Screw perforation scriptive statistics. Normal distribution trauma cement (PMMA). The lengths of 2. Loss of fixation was tested with the Kolmogorov–S- the humeral head screws were selected 3. Fragment displacement mirnoff test and could not be assumed. so that their tips extended to the sub- 4. Bony fracture consolidation The results of two different follow-up chondral surface of the humeral head 5. Avascular necrosis of the humeral time points within the same group were without penetration of the articular sur- head and/or the tuberosities compared with the use of the Wilcoxon face. The surgeries were performed ac- 6. Implant loosening. matched-pair test. The results of the cording to the manufacturer’s instruc- different groups (augmented PHILOS tions and guidelines via the deltopectoral The clinical examination at the 3-month versus conventional PHILOS) were com- approachbyfive differentorthopedic sur- and 12-month follow-up included assess- pared with the Mann–Whitney U test. geons, all familiar with PHF treatment. If ment of the active range of shoulder The significance level was set at p< 0.05. the fracture involved the bicipial groove, motion, the Constant score as well as The chi-square test was used to investi- an epiosseous so-ft tissue tenodesis of the the age- and gender adjusted Constant gate any associations between the type of long head of the biceps tendon was per- score of both the affected and nonaffected fixation used and the likelihood of early formed. The arm was put in a sling for shoulders [19]. In addition, the Sim- loss of reduction and screw perforation comfort only for the first week postop- ple Shoulder Test (SST) [20], the Simple within the first 6 months postoperative. eratively. Free passive and active range Shoulder Value (SSV) [21], and the aver- To overcome grouping bias, the like- 124 Obere Extremität 2 · 2018 Abstract · Zusammenfassung Obere Extremität 2018 · 13:123–129 https://doi.org/10.1007/s11678-018-0440-x © The Author(s) 2018. This article is an open access publication. J. C. Katthagen ·O.Lutz · C. Voigt·H. Lill ·A.Ellwein Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures Abstract on postoperative radiographs. The CS and a significantly increased risk of early loss of Background. Cement augmentation (CA) of complications were compared with the reduction and articular screw perforation humeral head screws in locked plating of outcomes of a matched group of 24 patients (p= 0.037). proximal humeral fractures (PHF) was found (mean age, 73.9 ± 9.4 years; 22 female) with Conclusion. Locked plating of proximal to be biomechanically beneficial. However, locked plating of displaced PHF without CA. humeral fractures with trauma cement clinical outcomes of this treatment have not Results. At the 3-month follow-up, the mean augmentation of humeral head screws could been well evaluated to date. CS was 59.9 ± 15.6 points, the mean SST be translated from the ex-vivo lab setting Objectives. To assess outcomes of locked was 7.5 ± 2.7 points, and the mean SSV was into the clinical situation without additional plating of PHF with additional CA and to 63.9 ± 21.7%. All scores significantly improved complications. Locked plating of displaced compare them with outcomes of conventional by the 12-month follow-up (p< 0.05; CS, PHF with additional cement augmentation locked plating without CA. 72.9 ± 17.7; SST, 9.2 ± 3.2; SSV, 77.2 ± 17.3%). showed similar clinical outcomes but reduced Methods. 24 patients (mean age, There were two cases (8%) of biological the rate of early implant-relatedcomplications 74.2 ± 10.1 years; 22 female) with displaced complications (n=1 varus malunion and compared to locked plating without additional PHF were prospectively enrolled and treated n = 1 humeral head necrosis). Compared with CA. with locked plating and additional CA. The locked plating without CA, no significant Constant score (CS), the Simple Shoulder differences were observed between the Keywords Test (SST), and the Simple Shoulder Value CS at the 3- (57.8 ± 13.4 points; p= 0.62) Humeral fractures, proximal · Shoulder · (SSV) were assessed 3 and 12 months and 12-month (73.0 ± 12.8 points; p= 0.99) Bone plates · Cementation · Postoperative postoperatively. Fracture healing and potential complications were evaluated follow-up. However, patients without CA had complications Zementaugmentation der Humeruskopfschrauben reduziert frühe, implantatassoziierte Komplikationen nach winkelstabiler Plattenosteosynthese dislozierter proximaler Humerusfrakturen Zusammenfassung etwaige Komplikationen evaluiert. Der CS zeigte sich bei Patienten mit konventioneller Hintergrund. Biomechanisch begünstigt und die Komplikationsrate wurden mit den Plattenosteosynthese ohne ZA ein signifikant die additive Zementaugmentation (ZA) Ergebnissen eines Matched-Pair-Kollektivs höheres Risiko für einen Repositionsverlust von Humeruskopfschrauben bei winkel- von 24Patienten (73,9±9,4Jahre;22w.) mit intraartikulärer Schraubenperforation stabiler Plattenosteosynthese proximaler mit winkelstabiler Plattenosteosynthese (p= 0,037). Humerusfrakturen (PHF) die Stabilität und dislozierter PHF ohne ZA verglichen. Schlussfolgerung. Die ZA von Humerus- Versagenslast. Bislang sind klinische Ergeb- Ergebnisse. Nach 3 Monaten betrug der kopfschrauben bei Plattenosteosynthese nisse dieser Versorgungsform weitgehend unbekannt. CS durchschnittlich 59,9 ± 15,6 Punkte, dislozierer PHF konnte ohne zusätzliche Ziel der Arbeit. Die Ergebnisse nach winkel- der SST lag bei 7,5 ± 2,7 Punkten und der Komplikationen aus dem biomechanischen stabiler Plattenosteosynthese dislozierter PHF SSV bei 63,9 ± 21,7 %. Sämtliche Scores Labor in die klinische Anwendung übertragen verbesserten sich zum 12-Monats-Zeitpunkt werden. Mit der additiven ZA bei winkelstabi- mit ZA sollten evaluiert und mit jenen ohne signifikant (p< 0,05; CS 72,9 ± 17,7 Punkte, ler Plattenosteosynthesevon PHF war die Rate ZA verglichen werden. SST 9,2 ± 3,2 Punkte; SSV 77,2 ± 17,3 %). an implantatassoziiertenKomplikationen im Methoden. In die Studie wurden 24 Patienten Bei 2 Patientinnen (8 %) wurden biologi- Vergleich zur winkelstabilen Plattenosteosyn- (durchschnittlich 74,2 ± 10,1 Jahre; 22 w.) mit sche Komplikationen beobachtet (n=1 these ohne ZA bei vergleichbaren klinischen dislozierten PHF prospektiv eingeschlossen Varuspseudarthrose und n=1 Humeruskopf- Ergebnissen reduziert. und mittels winkelstabiler Plattenosteosyn- nekrose). Beim Vergleich mit dem CS der these mit additiver ZA operativ behandelt. Patienten mit winkelstabiler Plattenosteosyn- Schlüsselwörter Nach 3 und 12 Monaten wurden der Constant these ohne ZA zeigten sich keine signifikanten Humerusfrakturen, proximale · Schulter · Kno- Score (CS), der Simple Shoulder Test (SST) Unterschiede 3 Monate (57,8 ± 13,4 Punkte; chenplatten · Zementierung · Postoperative sowie der Simple Shoulder Value (SSV) p= 0,62) sowie 12 Monate (73,0 ± 12,8 Komplikationen erhoben. Anhand von Röntgenbildern Punkte; p= 0,99) postoperativ. Allerdings wurden die knöcherne Konsolidierung sowie lihood for early loss of reduction and ticipate, and two patients had preexisting Results articular screw perforation was addi- neurologic diseases with impairment of tionally compared for the augmented Ten patients were excluded from the the upper extremity. Of the remaining PHILOS group versus the entire historic study: two patients died before final 29 patients, five were lost to follow-up cohort of 74 patients with use of the chi- follow-up due to non-fracture-related and 24 patients (22 female, two male) square test. comorbidities, sixpatients refused topar- with a mean age of 74.2 ± 10.3 years Obere Extremität 2 · 2018 125 Original Contribution mary screw perforation, fragment dis- placement, or implant failure was seen. According to Schnetzke et al., the reduc- tion was anatomical or acceptable in all cases [8]. Radiological follow-up Radiological follow-up at a mean of 3.3 months postoperatively revealed no secondary screw perforation and there was no case of secondary fragment dis- placement or loss of fixation (. Figs. 1, 2, and 3). According to Schnetzke et al., the reduction was anatomical or acceptable in all cases without changes to a situation defined as malreduced compared with the situation on the second day aeft r surgery. The NSA averaged 131.1 ± 8.4° at thetimeofthe radiological follow-up, with the average loss of reduction being 4.6 ± 7.2°. Fig. 2 8 Postoperative radiographs of an 87-year-old female patient after locked plating of a proxi- mal humeral fracture (see .Fig. 1) with additional cement augmentation of the anterosuperior and Clinical follow-up inferior humeral head screws (a anteroposterior, b axillary view) All functional outcomes improved from the 3-month to the 12-month follow- up (. Table 1). At 3-months postoper- atively, no neurovascular complications or infections were observed. Six out of 24 patients (25%) had an early arthro- scopic revision surgery with arthrolysis, biceps tenotomy, and arthroscopicallyas- sisted implant removal between 3 and 5 months after the initial facture fixation. Intraoperative inspection of the humeral head articulating surface confirmed no articular screw perforation. The revi- sion surgeries were performed in patients with high functional expectations but limited postoperative range of motion. At12monthspostoperatively, theaverage age- and gender- related Constant score was rated excellent with 100 ± 28.6%, the average SST was 9.2 ± 3.3 out of 12 pos- Fig. 3 8 Radiographs 3 months afterlockedplatingofa proximal humeral fracture (see .Fig. 1)with sible points (. Table 1). At the final 12- additional cement augmentation of the anterosuperior and inferior humeral head screws showing month follow-up, two patients (8%) had fracture union without implant related complications (a anteroposterior, b axillary view) major biological complications. One pa- tient suffered from varus nonunion due (range, 52–96 years) participated in final had a four-part fracture according to the to a large defect zone in the subcapital follow-up (83%). Codman segment theory [15]. The frac- calcar region. Another patient sustained All 24 patients (100%) were available tures were classified as varus-displaced an avascular necrosis of the humeral head for the 3-month follow-up as well as for in 14 and as valgus-displaced fractures with collapse of the articulating surface. the 12-month examination. Three of the in ten cases according to Resch et al. No implant-related complications were 24 patients had a two-partfracture, 17 pa- [16]. The NSA averaged 135.3 ± 6.3° on observed. tients had a three-part, and four patients the second postoperative day and no pri- 126 Obere Extremität 2 · 2018 Table 1 Clinical and functional results after PHF fixation with the PHILOS plate with additional trauma cement augmentation of humeral head screws VAS pain Abduction CS Age- and gen- SST SSV der-adapted CS 3 months postop- 3.2 ± 2.7 107.3 ± 33.7° 59.9 ± 15.9 points 88.5 ± 26.7% 7.5 ± 2.8 points 63.9 ± 21.7% eratively (n= 24/24) 12 months post- 1.8 ± 2.1 127.9 ± 38.1° 72.9 ± 18.1 points 100 ± 28.6% 9.2 ± 3.3 points 77.2 ± 17.7% operatively (n= 24/24) a a a a a a p 0.025 0.006 <0.001 <0.001 0.01 0.001 CS Constant score,PHF proximal humeral fracture, SST Simple Shoulder Test, VAS visual analog scale, SSV Simple Shoulder Value Statistically significant dieff rence between the 3- and 12-month follow-ups locked plating. Furthermore, the addi- Table 2 Comparison ofpatient characteristics andfunctional outcomes in conventional PHILOS vs. cement-augmented PHILOS groups tional use of cement augmentation of PHILOS with cement Conventional PHILOS p the humeral head screws significantly augmentation of without cement reduced the rate of early implant-related humeral head screws augmentation complications. CS after 3 months 59.9 ± 15.9 57.8 ± 13.7 0.853 Locked plating is commonly used for CS after 12 months 72.9 ± 18.1 73.0 ± 13.1 0.557 the treatment of displaced PHF. How- CS affected side/CS nonaf- 82.2 ± 20.0% 84.1 ± 12.9% 0.496 ever, owing to the mainly osteoporotic fected side after 12 months bone structure of the affected older pa- CS Constant score tient population and the associated diffi- cult screw anchorage, complication rates are still high. Common complications more screw perforations in the context are primary and secondary screw perfo- Comparison with conventional of varuslossof reduction, whereasno ration of the articular surface and varus locked plating without cement such complication was observed within loss of reduction. Cement augmentation augmentation the first 6 months postoperatively in by filling bony voids in the humeral head The gender of the 24 patients treated with the cement-augmented PHILOS group. to improve the humeral head stability has the conventional PHILOS plate without Patients treated with the conventional been used for years; however, this pro- trauma cement augmentation matched PHILOS plate without cement augmen- cedure seems most applicable to the less in all cases. Age differed by 1–7 years in tation of humeral head screws were common valgus-impacted PHF [22]. 18 patients without significant difference significantly more likely to suffer from In 2012, Unger et al. presented the between the mean age of both groups early loss of reduction with articular results of a cadaveric study in which (augmented PHILOS, 74.2 ± 10.3 years; screw perforations than were patients the biomechanical properties of PHF conventional PHILOS, 73.7 ± 9.7 years; treated with cement augmentation of fixation with conventional locked plat- p= 0.925). The affected side differed in the humeral head screws (p= 0.037). ing was compared with locked plating four patients, one patient in the conven- The likelihood of early loss of reduction with additional cement augmentation tional PHILOS group had a less complex and articular screw perforation of the of the humeral head screws [11]. The two-part fracture instead of a three- entire historic cohort (n= 19 out of 74) authors observed significantly more cy- part fracture, and one patient in the was also statistically significantly higher cles to failure with cement-augmented conventional PHILOS group had a more when compared with the group of pa- humeral head screws compared with complex four-part fracture instead of tients with locked plating and additional conventional, nonaugmented screws. a three-part fracture compared with the cement augmentation (n= 0 out of 24; Furthermore, failure load did correlate cement-augmented PHILOS group. Re- p= 0.006). with the humeral head bone mineral den- sults were available for all 24 patients sity (BMD) in patients without cement (100%) in the matched conventional augmentation, but not when cement aug- Discussion PHILOS cohort at the 3-month and 12- mentation of the humeral head screws month follow-up. No significant differ- The most important finding of this study was used. The improved stability of ences were observed between functional was that locked plating of PHF with PHF fixation with cement augmentation outcomes in both groups aeft r 3 months trauma cement augmentation of humeral of humeral head screws was confirmed and after 12 months ( p> 0.05; . Table 2). head screws can be translated from the by subsequent biomechanical studies. Within the first 6 months postopera- ex vivo lab setting into the clinical Röderer et al. showed that the screw tively, four patients in the conventional situation without additional complica- augmentation could compensate for PHILOS group had suffered one or tions when compared with conventional alow BMD, andKathrein etal. found Obere Extremität 2 · 2018 127 Original Contribution decreased per cycle motion and de- Nonunion and avascular necrosis of Corresponding address creased varus impaction when humeral the humeral head that were observed in head screw tips were augmented with two patients after locked plating with ce- Dr. J.C.Katthagen trauma cement [12, 13]. Since harden- ment augmented humeral head screws Department of Trauma, Hand and Reconstructive Surgery, ing of the cement is accompanied by are biologic complications that are related Universitätsklinikum Münster an exothermic reaction, Blazejak et al. to the humeral head anatomy and blood Albert-Schweitzer-Str. 1, investigated whether heat development supply and not necessarily to the type 48149 Münster, Germany during augmentation may set the sub- of humeral head fixation. Both types of christoph.katthagen@ ukmuenster.de chondral bone and the chondral surface biologic complications have been found at risk for necrosis and apoptosis [23]. with an incidence of up to 10% within Augmentation of the proximal screws the first 12 months postoperatively aeft r of the PHILOS plate with PMMA led locked plating without additional cement Compliance with ethical to a locally limited development of augmentation and should therefore be guidelines supraphysiological temperatures in the viewed as nonimplant-related complica- cement cloud and closely around it. The tions[26, 27]. Furthermore, bothtypesof Conflict of interest. J. C. Katthagen and H. Lill critical threshold value for necrosis and complications have been described in the serve on the speakers’ bureau of and have received honoraria from DePuy Synthes (Umkirch, Germany) apoptosis of cartilage and subchondral Boileauclassificationofso-calledfracture andfromArthrex(Karlsfeld,Germany). O.Lutz,C.Voigt, bone reported in the literature, however, sequelae and can be observed after op- and A. Ellwein declare that they have no competing was not reached. Beside concerns with erative as well as nonoperative treatment interests. the thermic reaction, the question was of PHF [28, 29]. All procedures performed in studies involving human raised of whether implants could still be participants were in accordance with the ethical stan- removed even if cement augmentation dards of the institutional and/or national research Limitations committee and with the 1964 Helsinki declaration and was used. Goetzen et al. showed that its later amendments or comparable ethical standards. screw removal was possible without any There are several limitations that must Informed consent was obtained from all individual problems despite cement augmentation be considered when interpreting the pre- participants included in the study. This study was IRB approved. [24]. This was clinically confirmed in sented findings. First, the retrospective this study, since implant removal was study design with a matched group com- Open Access This article is distributedunder the terms performed without problems in six pa- parison of a historic patient group has of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/ tients with cement-augmented humeral inherent bias. Second, no measurement 4.0/), which permits unrestricted use, distribution, screws. In a more recent biomechan- of bone quality was available or reli- and reproduction in any medium, provided you give ical study, Schliemann et al. reported ably feasible in a retrospective fashion. appropriate credit to the original author(s) and the source, providealinktotheCreativeCommonslicense, that augmentation of anterior humeral Third, itwas notevaluated whether fix- and indicate if changes were made. head screws reduced the motion at the ation failures, on one hand, and early bone–implant interface [14]. arthroscopic revision surgeries, on the The presented outcomes of this case other hand, had an impact on the final References series of patients treated with cement- clinical outcome. Future investigations 1. 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Resch H, Tauber M, Neviaser RJ, Neviaser AS, Majed A, Halsey T, Hirzinger C, Al-Yassari G, Zyto K, Moroder P (2016) Classification of proximal humeral fractures based on a pathomorphological analysis. JShoulderElbowSurg25(3):455–462 17. Hertel R, Knothe U, Ballmer FT (2002) Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg 11(4):331–338 18. KatthagenJC,EllweinA,LutzO,VoigtC,LillH(2017) Outcomes of proximal humeral fracture fixation with locked CFR-PEEK plating. Eur J Orthop Surg Traumatol27(3):351–358 19. Constant CR, Gerber C, Emery RJH, Sojbjerg JO, Gohlke F, Boileau P (2003)A review of the constant score: modifications and guidelines for its use. JShoulderElbowSurg17(2):355–361 20. Lippitt SB, Harryman DT II, Matsen FA III (1993) A practical tool for evaluating function: the simple shoulder test. In: Matsen FA III, Fu FH, Hawkins RJ (eds) The shoulder: a balance of mobility and stability. American Academy of Orthopaedic Surgeons,Rosement,pp545–559 21. Fuchs B, Jost B, Gerber C (2000) Posterior-inferior capsular shift for the treatment of recurrent, Obere Extremität 2 · 2018 129 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Obere Extremität Springer Journals

Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures

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Original Contribution 1,2 1 1 1 1 Obere Extremität 2018 · 13:123–129 J. Christoph Katthagen ·O.Lutz ·C.Voigt ·H.Lill ·A.Ellwein https://doi.org/10.1007/s11678-018-0440-x Department of Orthopaedic and Trauma Surgery, DIAKOVERE Friederikenstift, Hannover, Germany Received: 11 October 2017 Department of Trauma, Hand and Reconstructive Surgery, Universitätsklinikum Münster, Münster, Accepted: 5 January 2018 Germany Published online: 30 January 2018 © The Author(s) 2018. This article is an open access publication. Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures Humeral head screw augmentation LOS plate (DePuy Synthes ,Umkirch, Introduction with polymethyl methacrylate (PMMA) Germany) along with additional humeral Locked plating of displaced proximal trauma cement has been shown to en- head screw augmentation with PMMA humeral fractures (PHF) poses a se- hance screw anchorage and to thereby trauma cement in this prospective case rious challenge to orthopedic trauma increase the primary stability of locked series. The study was approved by the surgeons. The biologic circumstances plating of displaced PHF in several institutional review board and informed of the mainly older patient population biomechanical studies [11–14]. The pri- consent was obtained from all individ- with osteoporotic bone stock make screw mary goal of this study was to evaluate ual participants included in the study. anchorage difficult [1–3]. The unique whether these in vitro findings can be Inclusion criteria were: mechanical setting with the humeral translated into daily clinical routine with- 1. Displaced unilateral PHF head articulating surface being loaded out additional complications compared 2. Age of at least 18 years against the screw tips and the rotator with conventional locked plating without 3. Written informed consent cuff pulling in an antero- and postero- additional trauma cement augmentation. medial direction demands for a fracture The secondary goal was to compare func- Patients were excluded from the study if fixation with immediate stability [4, 5]. tional outcomes and complication rates they: However, the ideal implant characteris- between locked plating of PHF with 4. Had a bilateral PHF and/or tics should make the construct flexible cement augmentation versus without 5. Had previous shoulder surgery or enough to unload the bone implant in- cement augmentation of humeral head a neurologic disease with impairment terface but rigid enough to minimize screws. We hypothesized that locked of the upper extremity and/or fracture movements [6]. plating of PHF with additional cement 6. Refused to participate Despite identification of several po- augmentation of humeral head screws tential risk factors for fixation failure can be used in clinical practice without Preoperative patient-specific data such and regardless of the continuous devel- additional complications and that early as age, gender, affected side, preexisting opment of implants with improved plate implant-related complications can be diseases and medications, as well as con- and screw design, the complication rate reduced compared with locked plating comitant fractures were noted. The PHF associated with locked plating of PHF is without additional cement augmentation were preoperatively classified according still high [2, 7, 8]. Especially in fragility of humeral head screws. the Codmansegmenttheoryand the clas- fractures of the older population, loss of sification suggested by Resch et al. [15, reduction with secondary articular screw 16]. The neck–shaft angle (NSA) was Methods perforation and varus displacement with measured on a standardized true antero- loss of fixation can still be observed in up Between February 2014 and Septem- posterior (AP) view on the second day af- to 20% of cases within the first 12 months ber 2015, 39 patients underwent fracture ter surgery [17]. X-rays were further an- postoperatively [9, 10]. fixation of a displaced PHF with the PHI- alyzed for primary screw perforation, for Obere Extremität 2 · 2018 123 Original Contribution age pain measured with the Visual Ana- log Scale (VAS) of the affected shoulder were assessed. Furthermore, all compli- cations and reoperations were evaluated and noted. Patients with conventional titanium locked plating A case-control cohort of 24 patients (two male, 22 female; mean age, 73.9 ± 9.4 years) treated with a conventional titanium locking plate was used to com- pare the Constant score and the com- plication rates with the results of the patients treated with additional cement augmentation of humeral head screws. These 24 patients derived from a historic retrospective cohort of 74 patients (54 fe- Fig. 1 8 Preoperative radiographs of an 87-year-old female patient with valgus-displaced three-part males, 20 males; mean age, 73 years) proximal humeral fracture (a anteroposterior, bYview) treated with the PHILOS PHF plate. The best match with regard to gender, age, displaced fragments, and for the quality of motion was allowed immediately af- affected side, and fracture complexity ac- of reduction according to Marc Schnet- ter surgery without weight-bearing for cordingtoCodman’ssegmenttheorywas zke et al. [8, 18]. Failure was defined 6 weeks. sought. The investigator who matched as a “malreduced” situation according to 24 patients of the historic PHILOS group Schnetzke et al. [8]. without additional cement augmenta- Functional and radiological tion was blinded to functional outcomes, follow-up complications, and reoperations. Apart Titanium plating with cement Patients were followed up clinically and from cement augmentation of humeral augmentation of humeral head radiologically at 3 months postopera- head screws, the operative technique and screws tively and again clinically at 12 months the postoperative rehabilitation protocol The PHILOS plate (DePuy Synthes )is postoperatively. At the 3-month follow- were identical to those of patients with made of titanium alloy. The shaft was up, patients had radiographs in two locked plating and additional cement fixed with three 3.5-mm screws in all planes (true AP and axial) unless pre- augmentation. cases. The number of 3.5-mm humeral vious radiographs had demonstrated head screws used ranged from 5 to 9 fracture consolidation. The NSA was Statistical analysis (on average, 7). An average of three measured again [17]. Furthermore, both cannulated humeral head screws (range, radiographic planes were evaluated for: All data was analyzed by means of de- 2–5) were augmented with 0.5–1 ml of 1. Screw perforation scriptive statistics. Normal distribution trauma cement (PMMA). The lengths of 2. Loss of fixation was tested with the Kolmogorov–S- the humeral head screws were selected 3. Fragment displacement mirnoff test and could not be assumed. so that their tips extended to the sub- 4. Bony fracture consolidation The results of two different follow-up chondral surface of the humeral head 5. Avascular necrosis of the humeral time points within the same group were without penetration of the articular sur- head and/or the tuberosities compared with the use of the Wilcoxon face. The surgeries were performed ac- 6. Implant loosening. matched-pair test. The results of the cording to the manufacturer’s instruc- different groups (augmented PHILOS tions and guidelines via the deltopectoral The clinical examination at the 3-month versus conventional PHILOS) were com- approachbyfive differentorthopedic sur- and 12-month follow-up included assess- pared with the Mann–Whitney U test. geons, all familiar with PHF treatment. If ment of the active range of shoulder The significance level was set at p< 0.05. the fracture involved the bicipial groove, motion, the Constant score as well as The chi-square test was used to investi- an epiosseous so-ft tissue tenodesis of the the age- and gender adjusted Constant gate any associations between the type of long head of the biceps tendon was per- score of both the affected and nonaffected fixation used and the likelihood of early formed. The arm was put in a sling for shoulders [19]. In addition, the Sim- loss of reduction and screw perforation comfort only for the first week postop- ple Shoulder Test (SST) [20], the Simple within the first 6 months postoperative. eratively. Free passive and active range Shoulder Value (SSV) [21], and the aver- To overcome grouping bias, the like- 124 Obere Extremität 2 · 2018 Abstract · Zusammenfassung Obere Extremität 2018 · 13:123–129 https://doi.org/10.1007/s11678-018-0440-x © The Author(s) 2018. This article is an open access publication. J. C. Katthagen ·O.Lutz · C. Voigt·H. Lill ·A.Ellwein Cement augmentation of humeral head screws reduces early implant-related complications after locked plating of proximal humeral fractures Abstract on postoperative radiographs. The CS and a significantly increased risk of early loss of Background. Cement augmentation (CA) of complications were compared with the reduction and articular screw perforation humeral head screws in locked plating of outcomes of a matched group of 24 patients (p= 0.037). proximal humeral fractures (PHF) was found (mean age, 73.9 ± 9.4 years; 22 female) with Conclusion. Locked plating of proximal to be biomechanically beneficial. However, locked plating of displaced PHF without CA. humeral fractures with trauma cement clinical outcomes of this treatment have not Results. At the 3-month follow-up, the mean augmentation of humeral head screws could been well evaluated to date. CS was 59.9 ± 15.6 points, the mean SST be translated from the ex-vivo lab setting Objectives. To assess outcomes of locked was 7.5 ± 2.7 points, and the mean SSV was into the clinical situation without additional plating of PHF with additional CA and to 63.9 ± 21.7%. All scores significantly improved complications. Locked plating of displaced compare them with outcomes of conventional by the 12-month follow-up (p< 0.05; CS, PHF with additional cement augmentation locked plating without CA. 72.9 ± 17.7; SST, 9.2 ± 3.2; SSV, 77.2 ± 17.3%). showed similar clinical outcomes but reduced Methods. 24 patients (mean age, There were two cases (8%) of biological the rate of early implant-relatedcomplications 74.2 ± 10.1 years; 22 female) with displaced complications (n=1 varus malunion and compared to locked plating without additional PHF were prospectively enrolled and treated n = 1 humeral head necrosis). Compared with CA. with locked plating and additional CA. The locked plating without CA, no significant Constant score (CS), the Simple Shoulder differences were observed between the Keywords Test (SST), and the Simple Shoulder Value CS at the 3- (57.8 ± 13.4 points; p= 0.62) Humeral fractures, proximal · Shoulder · (SSV) were assessed 3 and 12 months and 12-month (73.0 ± 12.8 points; p= 0.99) Bone plates · Cementation · Postoperative postoperatively. Fracture healing and potential complications were evaluated follow-up. However, patients without CA had complications Zementaugmentation der Humeruskopfschrauben reduziert frühe, implantatassoziierte Komplikationen nach winkelstabiler Plattenosteosynthese dislozierter proximaler Humerusfrakturen Zusammenfassung etwaige Komplikationen evaluiert. Der CS zeigte sich bei Patienten mit konventioneller Hintergrund. Biomechanisch begünstigt und die Komplikationsrate wurden mit den Plattenosteosynthese ohne ZA ein signifikant die additive Zementaugmentation (ZA) Ergebnissen eines Matched-Pair-Kollektivs höheres Risiko für einen Repositionsverlust von Humeruskopfschrauben bei winkel- von 24Patienten (73,9±9,4Jahre;22w.) mit intraartikulärer Schraubenperforation stabiler Plattenosteosynthese proximaler mit winkelstabiler Plattenosteosynthese (p= 0,037). Humerusfrakturen (PHF) die Stabilität und dislozierter PHF ohne ZA verglichen. Schlussfolgerung. Die ZA von Humerus- Versagenslast. Bislang sind klinische Ergeb- Ergebnisse. Nach 3 Monaten betrug der kopfschrauben bei Plattenosteosynthese nisse dieser Versorgungsform weitgehend unbekannt. CS durchschnittlich 59,9 ± 15,6 Punkte, dislozierer PHF konnte ohne zusätzliche Ziel der Arbeit. Die Ergebnisse nach winkel- der SST lag bei 7,5 ± 2,7 Punkten und der Komplikationen aus dem biomechanischen stabiler Plattenosteosynthese dislozierter PHF SSV bei 63,9 ± 21,7 %. Sämtliche Scores Labor in die klinische Anwendung übertragen verbesserten sich zum 12-Monats-Zeitpunkt werden. Mit der additiven ZA bei winkelstabi- mit ZA sollten evaluiert und mit jenen ohne signifikant (p< 0,05; CS 72,9 ± 17,7 Punkte, ler Plattenosteosynthesevon PHF war die Rate ZA verglichen werden. SST 9,2 ± 3,2 Punkte; SSV 77,2 ± 17,3 %). an implantatassoziiertenKomplikationen im Methoden. In die Studie wurden 24 Patienten Bei 2 Patientinnen (8 %) wurden biologi- Vergleich zur winkelstabilen Plattenosteosyn- (durchschnittlich 74,2 ± 10,1 Jahre; 22 w.) mit sche Komplikationen beobachtet (n=1 these ohne ZA bei vergleichbaren klinischen dislozierten PHF prospektiv eingeschlossen Varuspseudarthrose und n=1 Humeruskopf- Ergebnissen reduziert. und mittels winkelstabiler Plattenosteosyn- nekrose). Beim Vergleich mit dem CS der these mit additiver ZA operativ behandelt. Patienten mit winkelstabiler Plattenosteosyn- Schlüsselwörter Nach 3 und 12 Monaten wurden der Constant these ohne ZA zeigten sich keine signifikanten Humerusfrakturen, proximale · Schulter · Kno- Score (CS), der Simple Shoulder Test (SST) Unterschiede 3 Monate (57,8 ± 13,4 Punkte; chenplatten · Zementierung · Postoperative sowie der Simple Shoulder Value (SSV) p= 0,62) sowie 12 Monate (73,0 ± 12,8 Komplikationen erhoben. Anhand von Röntgenbildern Punkte; p= 0,99) postoperativ. Allerdings wurden die knöcherne Konsolidierung sowie lihood for early loss of reduction and ticipate, and two patients had preexisting Results articular screw perforation was addi- neurologic diseases with impairment of tionally compared for the augmented Ten patients were excluded from the the upper extremity. Of the remaining PHILOS group versus the entire historic study: two patients died before final 29 patients, five were lost to follow-up cohort of 74 patients with use of the chi- follow-up due to non-fracture-related and 24 patients (22 female, two male) square test. comorbidities, sixpatients refused topar- with a mean age of 74.2 ± 10.3 years Obere Extremität 2 · 2018 125 Original Contribution mary screw perforation, fragment dis- placement, or implant failure was seen. According to Schnetzke et al., the reduc- tion was anatomical or acceptable in all cases [8]. Radiological follow-up Radiological follow-up at a mean of 3.3 months postoperatively revealed no secondary screw perforation and there was no case of secondary fragment dis- placement or loss of fixation (. Figs. 1, 2, and 3). According to Schnetzke et al., the reduction was anatomical or acceptable in all cases without changes to a situation defined as malreduced compared with the situation on the second day aeft r surgery. The NSA averaged 131.1 ± 8.4° at thetimeofthe radiological follow-up, with the average loss of reduction being 4.6 ± 7.2°. Fig. 2 8 Postoperative radiographs of an 87-year-old female patient after locked plating of a proxi- mal humeral fracture (see .Fig. 1) with additional cement augmentation of the anterosuperior and Clinical follow-up inferior humeral head screws (a anteroposterior, b axillary view) All functional outcomes improved from the 3-month to the 12-month follow- up (. Table 1). At 3-months postoper- atively, no neurovascular complications or infections were observed. Six out of 24 patients (25%) had an early arthro- scopic revision surgery with arthrolysis, biceps tenotomy, and arthroscopicallyas- sisted implant removal between 3 and 5 months after the initial facture fixation. Intraoperative inspection of the humeral head articulating surface confirmed no articular screw perforation. The revi- sion surgeries were performed in patients with high functional expectations but limited postoperative range of motion. At12monthspostoperatively, theaverage age- and gender- related Constant score was rated excellent with 100 ± 28.6%, the average SST was 9.2 ± 3.3 out of 12 pos- Fig. 3 8 Radiographs 3 months afterlockedplatingofa proximal humeral fracture (see .Fig. 1)with sible points (. Table 1). At the final 12- additional cement augmentation of the anterosuperior and inferior humeral head screws showing month follow-up, two patients (8%) had fracture union without implant related complications (a anteroposterior, b axillary view) major biological complications. One pa- tient suffered from varus nonunion due (range, 52–96 years) participated in final had a four-part fracture according to the to a large defect zone in the subcapital follow-up (83%). Codman segment theory [15]. The frac- calcar region. Another patient sustained All 24 patients (100%) were available tures were classified as varus-displaced an avascular necrosis of the humeral head for the 3-month follow-up as well as for in 14 and as valgus-displaced fractures with collapse of the articulating surface. the 12-month examination. Three of the in ten cases according to Resch et al. No implant-related complications were 24 patients had a two-partfracture, 17 pa- [16]. The NSA averaged 135.3 ± 6.3° on observed. tients had a three-part, and four patients the second postoperative day and no pri- 126 Obere Extremität 2 · 2018 Table 1 Clinical and functional results after PHF fixation with the PHILOS plate with additional trauma cement augmentation of humeral head screws VAS pain Abduction CS Age- and gen- SST SSV der-adapted CS 3 months postop- 3.2 ± 2.7 107.3 ± 33.7° 59.9 ± 15.9 points 88.5 ± 26.7% 7.5 ± 2.8 points 63.9 ± 21.7% eratively (n= 24/24) 12 months post- 1.8 ± 2.1 127.9 ± 38.1° 72.9 ± 18.1 points 100 ± 28.6% 9.2 ± 3.3 points 77.2 ± 17.7% operatively (n= 24/24) a a a a a a p 0.025 0.006 <0.001 <0.001 0.01 0.001 CS Constant score,PHF proximal humeral fracture, SST Simple Shoulder Test, VAS visual analog scale, SSV Simple Shoulder Value Statistically significant dieff rence between the 3- and 12-month follow-ups locked plating. Furthermore, the addi- Table 2 Comparison ofpatient characteristics andfunctional outcomes in conventional PHILOS vs. cement-augmented PHILOS groups tional use of cement augmentation of PHILOS with cement Conventional PHILOS p the humeral head screws significantly augmentation of without cement reduced the rate of early implant-related humeral head screws augmentation complications. CS after 3 months 59.9 ± 15.9 57.8 ± 13.7 0.853 Locked plating is commonly used for CS after 12 months 72.9 ± 18.1 73.0 ± 13.1 0.557 the treatment of displaced PHF. How- CS affected side/CS nonaf- 82.2 ± 20.0% 84.1 ± 12.9% 0.496 ever, owing to the mainly osteoporotic fected side after 12 months bone structure of the affected older pa- CS Constant score tient population and the associated diffi- cult screw anchorage, complication rates are still high. Common complications more screw perforations in the context are primary and secondary screw perfo- Comparison with conventional of varuslossof reduction, whereasno ration of the articular surface and varus locked plating without cement such complication was observed within loss of reduction. Cement augmentation augmentation the first 6 months postoperatively in by filling bony voids in the humeral head The gender of the 24 patients treated with the cement-augmented PHILOS group. to improve the humeral head stability has the conventional PHILOS plate without Patients treated with the conventional been used for years; however, this pro- trauma cement augmentation matched PHILOS plate without cement augmen- cedure seems most applicable to the less in all cases. Age differed by 1–7 years in tation of humeral head screws were common valgus-impacted PHF [22]. 18 patients without significant difference significantly more likely to suffer from In 2012, Unger et al. presented the between the mean age of both groups early loss of reduction with articular results of a cadaveric study in which (augmented PHILOS, 74.2 ± 10.3 years; screw perforations than were patients the biomechanical properties of PHF conventional PHILOS, 73.7 ± 9.7 years; treated with cement augmentation of fixation with conventional locked plat- p= 0.925). The affected side differed in the humeral head screws (p= 0.037). ing was compared with locked plating four patients, one patient in the conven- The likelihood of early loss of reduction with additional cement augmentation tional PHILOS group had a less complex and articular screw perforation of the of the humeral head screws [11]. The two-part fracture instead of a three- entire historic cohort (n= 19 out of 74) authors observed significantly more cy- part fracture, and one patient in the was also statistically significantly higher cles to failure with cement-augmented conventional PHILOS group had a more when compared with the group of pa- humeral head screws compared with complex four-part fracture instead of tients with locked plating and additional conventional, nonaugmented screws. a three-part fracture compared with the cement augmentation (n= 0 out of 24; Furthermore, failure load did correlate cement-augmented PHILOS group. Re- p= 0.006). with the humeral head bone mineral den- sults were available for all 24 patients sity (BMD) in patients without cement (100%) in the matched conventional augmentation, but not when cement aug- Discussion PHILOS cohort at the 3-month and 12- mentation of the humeral head screws month follow-up. No significant differ- The most important finding of this study was used. The improved stability of ences were observed between functional was that locked plating of PHF with PHF fixation with cement augmentation outcomes in both groups aeft r 3 months trauma cement augmentation of humeral of humeral head screws was confirmed and after 12 months ( p> 0.05; . Table 2). head screws can be translated from the by subsequent biomechanical studies. Within the first 6 months postopera- ex vivo lab setting into the clinical Röderer et al. showed that the screw tively, four patients in the conventional situation without additional complica- augmentation could compensate for PHILOS group had suffered one or tions when compared with conventional alow BMD, andKathrein etal. found Obere Extremität 2 · 2018 127 Original Contribution decreased per cycle motion and de- Nonunion and avascular necrosis of Corresponding address creased varus impaction when humeral the humeral head that were observed in head screw tips were augmented with two patients after locked plating with ce- Dr. J.C.Katthagen trauma cement [12, 13]. Since harden- ment augmented humeral head screws Department of Trauma, Hand and Reconstructive Surgery, ing of the cement is accompanied by are biologic complications that are related Universitätsklinikum Münster an exothermic reaction, Blazejak et al. to the humeral head anatomy and blood Albert-Schweitzer-Str. 1, investigated whether heat development supply and not necessarily to the type 48149 Münster, Germany during augmentation may set the sub- of humeral head fixation. Both types of christoph.katthagen@ ukmuenster.de chondral bone and the chondral surface biologic complications have been found at risk for necrosis and apoptosis [23]. with an incidence of up to 10% within Augmentation of the proximal screws the first 12 months postoperatively aeft r of the PHILOS plate with PMMA led locked plating without additional cement Compliance with ethical to a locally limited development of augmentation and should therefore be guidelines supraphysiological temperatures in the viewed as nonimplant-related complica- cement cloud and closely around it. The tions[26, 27]. Furthermore, bothtypesof Conflict of interest. J. C. Katthagen and H. Lill critical threshold value for necrosis and complications have been described in the serve on the speakers’ bureau of and have received honoraria from DePuy Synthes (Umkirch, Germany) apoptosis of cartilage and subchondral Boileauclassificationofso-calledfracture andfromArthrex(Karlsfeld,Germany). O.Lutz,C.Voigt, bone reported in the literature, however, sequelae and can be observed after op- and A. Ellwein declare that they have no competing was not reached. Beside concerns with erative as well as nonoperative treatment interests. the thermic reaction, the question was of PHF [28, 29]. All procedures performed in studies involving human raised of whether implants could still be participants were in accordance with the ethical stan- removed even if cement augmentation dards of the institutional and/or national research Limitations committee and with the 1964 Helsinki declaration and was used. Goetzen et al. showed that its later amendments or comparable ethical standards. screw removal was possible without any There are several limitations that must Informed consent was obtained from all individual problems despite cement augmentation be considered when interpreting the pre- participants included in the study. This study was IRB approved. [24]. This was clinically confirmed in sented findings. First, the retrospective this study, since implant removal was study design with a matched group com- Open Access This article is distributedunder the terms performed without problems in six pa- parison of a historic patient group has of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/ tients with cement-augmented humeral inherent bias. Second, no measurement 4.0/), which permits unrestricted use, distribution, screws. In a more recent biomechan- of bone quality was available or reli- and reproduction in any medium, provided you give ical study, Schliemann et al. reported ably feasible in a retrospective fashion. appropriate credit to the original author(s) and the source, providealinktotheCreativeCommonslicense, that augmentation of anterior humeral Third, itwas notevaluated whether fix- and indicate if changes were made. head screws reduced the motion at the ation failures, on one hand, and early bone–implant interface [14]. arthroscopic revision surgeries, on the The presented outcomes of this case other hand, had an impact on the final References series of patients treated with cement- clinical outcome. Future investigations 1. SinghA,AdamsAL,BurchetteR,DellRM,Funahashi augmented proximal humeral locked with prospective randomized compar- TT, Navarro RA (2015) The effect of osteoporosis plating support the biomechanical find- isons of both fracture fixation techniques management on proximal humeral fracture. ings in preceding studies. Compared and with evaluation of the influence of JShoulderElbowSurg24(2):191–198 2. HardemanF,BollarsP,DonnellyM,BellemansJ,Nijs with locked plating of PHF without bone quality are warranted. S (2012) Predictive factors for functional outcome cement augmentation of humeral head and failure in angular stable osteosynthesis of the proximalhumerus. Injury43(2):153–158 screws, significantly fewer screw perfo- Conclusion 3. Katthagen JC, Grabowski S, Huber M, Jensen G, rations of the humeral head articulating Voigt C, Lill H (2016) Epidemiology and treatment surface were observed. 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Obere ExtremitätSpringer Journals

Published: Jan 30, 2018

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