613 C OPYRIGHT Ó 2015 BY T HE J OURNAL OF B ONE AND J OINT S URGERY, I NCORPORATED Operative Treatment of Dislocated Midshaft Clavicular Fractures: Plate or Intramedullary Nail Fixation? A Randomized Controlled Trial Olivier A. van der Meijden, MD, PhD, R. Marijn Houwert, MD, PhD, Martijn Hulsmans, MD, Frans-Jasper G. Wijdicks, MD, PhD, Marcel G.W. Dijkgraaf, PhD, Sven A.G. Meylaerts, MD, PhD, Eric R. Hammacher, MD, PhD, Michiel H.J. Verhofstad, MD, PhD, and Egbert J.M.M. Verleisdonk, MD, PhD Investigation performed at the Diakonessenhuis, Utrecht; Academic Medical Center, Amsterdam; Medical Center Haaglanden, The Hague; St. Antonius Hospital, Nieuwegein; St. Elisabeth Hospital, Tilburg; and Erasmus Medical Center, Rotterdam, the Netherlands Background: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. Methods: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. Results: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). Conclusions: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors. O ver the past decades, there has been a shift toward the operative treatment of displaced midshaft clavicular fractures. The rationale for operative fixation includes reported higher nonunion rates and increased functional deficits following nonoperative treatment of displaced midshaft clavicular fractures1-5. Two of the most commonly used techniques for Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article. J Bone Joint Surg Am. 2015;97:613-9 d http://dx.doi.org/10.2106/JBJS.N.00449 614 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d operative treatment are (1) open reduction and internal plate fixation and (2) intramedullary nailing6. The optimal fixation method for these types of fractures remains a topic of debate. A plate provides immediate rigid fixation, including rotational stability, which is favorable for early rehabilitation protocols and may be technically less demanding7,8. Intramedullary fixation is in general less invasive, good cosmetic results have been reported, and the implant is less prominent4. Despite proposed benefits, each technique has its drawbacks. Infection, hypertrophic scarring, and irritation by and even failure of the implants have been reported following plate fixation9. Intramedullary nails often require routine removal to prevent them from migrating and, prior to this, they may cause irritation10. The purpose of this multicenter, randomized controlled trial was to report the functional results and complication rates of patients, eighteen to sixty-five years of age, who were randomized to receive either open reduction and plate fixation or intramedullary nail fixation for a displaced midshaft clavicular fracture (Plate or Pin [POP] study)11. The null hypothesis was that plate fixation would provide faster functional recovery than intramedullary nail fixation. Materials and Methods Study Design T he POP study, registered in the Dutch Trial Register (NTR 2438), was per12 formed in accordance with the Declaration of Helsinki and approved by the local medical ethics committee (registration number V.10.365/R-10.18D/mg). From January 2011 until August 2012, 120 consecutive patients with a displaced midshaft clavicular fracture were included in this prospective trial in four participating hospitals. Displacement was defined as at least one shaft width of distance on any radiograph between major fracture fragments, regardless of fracture shortening. Power Analysis and Randomization The sample size of sixty patients per group was based on an assumed clinically relevant difference in the Disabilities of the Arm, Shoulder and Hand (DASH) score of 6 points between the score of a healthy population and previously reported scores following conservative treatment of displaced midshaft clavicular 1,13 fractures . A more detailed rationale can be found in a previous description of 11 the study protocol . Patients were recruited in the emergency departments and handed study information if they met the inclusion criteria (Table I). Follow-up was scheduled within a week after the trauma for study inclusion after informed consent was obtained. Fractures were classified according to the AO/OTA classification for clavicular fractures. Randomization to either plate fixation or intramedullary nailing was performed by central computerized block randomization in the doctor’s office. Analysis after treatment was carried out according to the intention-to-treat principle. Block sizes ranged from two to eight patients with the two operative techniques equally represented in each block. Additionally, the randomization procedure 11 was stratified by participating center . Operative Technique Plate Fixation A single dose of prophylactic antibiotics was administered preoperatively. Patients were placed in the beach-chair position and prepared in a standard fashion. A longitudinal incision parallel to the clavicle, the length of which depended on the fractured segment, was made, and the fracture was identified. Following fracture reduction, a plate (DePuy Synthes, Amersfoort, the Netherlands) was positioned on the anterosuperior surface of the clavicle and fixed with nonlocking and locking screws. The type of plate was selected according to the surgeon’s prefer- P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D ence. A minimum of three bicortical screws was placed on each side of the fracture to ensure rigid fixation. If interfragmentary compression was possible, lag screws were placed first. Only fractures with severe comminution were 11 treated with a bridging plate . Intramedullary Nailing Following administration of a single dose of prophylactic antibiotics, patients were positioned in a supine position on a radiolucent table. A small incision was made just lateral to the sternoclavicular joint, and the anterior cortex was opened with a pointed reamer. A titanium elastic nail (DePuy Synthes, or Stryker, Waardenburg, the Netherlands) was inserted from the medial side under fluoroscopic control. Fractures were reduced closed under image intensification with percutaneous clamps or, if closed reduction failed, in an open fashion with use of an additional small incision over the fracture site, parallel to the clavicle. The length of the incision was variable and at the discretion of the treating surgeon. After complete introduction of the nail into the lateral fragment and compression of the fracture, 11 the nail was cut at the introduction point . Postoperative Rehabilitation and Follow-up Regardless of the type of operative fixation, patients were given a sling for comfort and encouraged to start active, non-weight-bearing mobilization as soon as pain permitted. Weight-bearing was permitted after fracture consolidation (bridging bone or callus formation) was demonstrated radiographically. All patients were followed clinically and radiographically in the outpatient clinic at two weeks, six weeks, three months, six months, and one year after surgery by the treating surgeon and an independent researcher (F.-J.G.W. or M.H.). Self-administered outcome questionnaires were completed prior to the actual follow-up appointment. Study End Points 11,13,14 The primary end point was the DASH score at six months . The DASH is a thirty-item subjective disability rating scale with scores ranging from 0 (no 13 disability) to 100 (complete disability) . DASH scores were also obtained at six weeks, three months, and one year after surgery, and the subjective shoulder function as measured by the DASH scores over the period between six weeks and six months after the operation was assessed. Secondary outcome measures included the Constant-Murley (CM) and 15,16 and a Likert scale for satisfaction with Short Form-36 (SF-36) questionnaires the cosmetic result (ranging from 0 for very unsatisfied and 10 for very satisfied). The CM score assesses shoulder pain, motion, strength, and function and was determined at the same time as the DASH score. Of the maximum score of 100 points, 35 points are derived from the patient’s self-assessment and 65 points 15 result from objective assessment . The SF-36 questionnaire, completed preoperatively and at six months and one year after surgery, measures health-related quality of life and consists of thirty-six items covering eight health-related domains. Responses are summed and then transformed into a scale from 0 (poor 16 health) to 100 (good health) for each domain . Recorded intraoperative data included the time of surgery, conversion of the fixation to the other type of fixation, performance of open reduction in patients undergoing intramedullary nail fixation, and neurovascular complications. Complications were classified with a strategy similar to those used in re9,10 and included infection (superficial or cently published systematic reviews deep), neurovascular problems (transient brachial plexus syndrome, hematoma, and desensitized skin), implant-related problems (soft-tissue irritation, breakage, and failure), bone-healing problems (nonunion and malunion), and finally refracture after implant removal. The definition of a superficial infection was redness, swelling, and/or purulent discharge from the wound. If the infection required surgical debridement and/or implant removal it was considered to be a deep infection. Brachial plexus lesions were defined as paresthesia of the arm and/ or weakness of the little and ring fingers. Lesions were considered transient if spontaneous recovery occurred within a six-month period. Soft-tissue irritation was defined as irritation due to a palpable implant. A lack of radiographic evidence of healing with clinical evidence of pain and motion at the fracture site six months after surgery was considered to indicate nonunion. Lastly, fracture union in a 615 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d shortened, angulated, or displaced position on radiographs with clinical symptoms was considered malunion. Statistical Analysis Data were analyzed according to the intention-to-treat principle. Baseline characteristics and postoperative outcome scores were compared by using either a Student t test or a Mann-Whitney U test for continuous variables (baseline: body mass index [BMI], age, and SF-36 domain scores; intraoperative: days between the fracture and surgery and the duration of surgery; and end points: DASH and CM scores at six months [comparison between study arms and between those who underwent conversion and those who did not within the study arms], DASH and CM scores during the six-month follow-up period, and SF-36 subscores [difference from baseline scores]). A Pearson chi-square test was used for categorical parameters. Interpolation of missing shoulder scores proved to be most in concordance with the complete case approach and was therefore used as the imputation method for missing follow-up data. A general linear random-effects model was run to study when differences in shoulder scores between the plate-fixation and nailing groups emerged during the first half year. P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D Bivariate correlations between continuous variables were tested by using a Pearson or Spearman rho test. The complication rates at one year after surgery were compared between the two interventions by using Poisson regression analysis. SPSS software (version 20.0; IBM, Armonk, New York) was used for data analysis. Significance was established at a p value of <0.05. Source of Funding This study was directly supported by an unrestricted CHF 90,500 research grant (Grant Number S-11-19V) by the AO Foundation (D¨ubendorf, Switzerland). Results Baseline and Intraoperative Findings f the 369 patients with a displaced midshaft clavicular fracture, 120 were enrolled in this study: fifty-eight were randomized to receive plate fixation and sixty-two, intramedullary nailing (Fig. 1). There were no significant differences O Fig. 1 Flowchart of inclusion in the POP (Plate or Pin) study for fixation of displaced midshaft clavicular fractures. 616 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D TABLE I Study Eligibility Criteria Inclusion Criteria Exclusion Criteria Unilateral, dislocated midshaft clavicular fracture Polytrauma Age 18-65 yr Open fracture No preexisting shoulder pathology on affected side Pathological fracture No medical contraindications to general anesthesia Fracture >1 mo old Ability to provide informed consent Neurovascular disorder Ability to comply with follow-up Moderate-to-severe head injury at time of trauma (Glasgow Coma Scale [GCS] <12) between the groups at baseline apart from the plate group having a lower SF-36 score for vitality (64.5 versus 72.6 points; p = 0.03) (Table II). At one year after surgery, three patients (3%), all in the plate group, had been lost to follow-up. These patients did not present for final follow-up. In the intramedullary nailing group, forty-six fractures (74%) were reduced in an open fashion. One patient (2%) in the plate group and six patients (10%) in the nailing group underwent intraoperative crossover to the other treatment group and were further analyzed as part of their original treatment group according to the intention-to-treat principle (see Appendix). There was no association between conversion to the other procedure and the outcome at six months (p = 0.42 in the nailing group; the plate group was not tested because only one patient underwent conversion). In addition, in the nailing group, there was no association between the time from fracture to surgery and the rate of open reduction (p = 0.97) or between open reduction and the outcome (p = 1.0). Primary and Secondary Outcomes Neither the mean DASH score nor the mean CM score at six months postoperatively differed significantly between the groups (Fig. 2). Until six months after surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH score (p = 0.02, Fig. 2-A). At one year after surgery, there was no difference between the groups in terms of satisfaction with the cosmetic appearance (p = 0.67). At six months, the bodily pain (p = 0.02) and vitality (p = 0.03) scores of the SF-36 subscales had improved more since baseline in the plate-fixation group than in the nailing group. At twelve months, the change in the vitality score since baseline was still greater (p = 0.02) in the plate-fixation group (see Appendix). Complications In the plate-fixation group, twenty-nine (50%) of the fifty-eight patients had a total of thirty-six complications (see Appendix). Fig. 2 Fig. 2-A The DASH scores were 10.8 (standard error of the mean [SEM] = 1.4), 4.63 (SEM = 1.0), 3.0 (SEM = 0.8), and 2.4 (SEM = 0.6) points at six, twelve, twenty-four, and fifty-two weeks following plate fixation and 15.1 (SEM = 1.7), 8.5 (SEM = 1.4), 5.6 (SEM = 1.3), and 3.9 (SEM = 1.1) points at the respective follow-up periods after intramedullary nailing. The area under the curve for the postoperative period of six weeks through six months is also displayed. Fig. 2-B The Constant-Murley scores were 91.9 (SEM = 1.4), 96.3 (SEM = 1.0), 96.0 (SEM = 0.8), and 99.2 (SEM = 0.4) points at six, twelve, twenty-four, and fifty-two weeks following plate fixation and 84.1 (SEM = 2.0), 91.1 (SEM = 1.8), 95.5 (SEM = 1.5), and 91.3 (SEM = 1.5) points at the respective follow-up periods after intramedullary nailing. 617 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D TABLE II Baseline Characteristics in Each Procedure Group Age* (yr) Plate Fixation (N = 58) Intramedullary Nailing (N = 62) P Value 38.4 ± 14.6 39.6 ± 13.2 0.64 53 (91%) 60 (97%) Sex† 0.21 Male Female Caucasian† 5 (9) 2 (3%) 57 (98%) 61 (98%) 0.37 24.7 (3.5) 24.2 (3.0) 0.36 19 (33%) 38 (66%) 20 (32%) 42 (68%) Yes 7 (12%) 7 (11%) No 51 (88%) 55 (89%) Right 50 (86%) 55 (89%) Left 8 (14%) 7 (11%) No 17 (29%) 20 (32%) Yes 41 (71%) 42 (68%) 30 (52%) 28 (48%) 29 (47%) 33 (53%) 28 (48%) 25 (40%) Sports 18 (31%) 29 (47%) Fall from stance/height/other 12 (21%) 8 (13%) Simple 27 (47%) 24 (39%) Wedge 29 (50%) 34 (55%) 2 (3%) 4 (6%) BMI* (kg/m2) Smoker† Yes No 0.90 Alcohol/drug abuse† 0.89 Hand dominance† 0.68 Sports activities† 0.73 Fracture side† Right Left Trauma mechanism† Traffic accident 0.59 0.17 Fracture classification†‡ Complex/comminuted 0.58 SF-36 score* (points) Physical functioning 54.2 ± 22.5 55.9 ± 22.3 0.68 Role-physical functioning Bodily pain 20.6 ± 38.1 36.9 ± 19.1 21.7 ± 34.3 41.9 ± 22.9 0.87 0.20 General health perception 80.7 ± 19.3 86.0 ± 16.1 0.16 Energy/fatigue (vitality) 64.5 ± 19.3 72.6 ± 20.5 0.03§ Social functioning 67.8 ± 30.2 75.4 ± 24.7 0.24 Role-emotional functioning 78.6 ± 38.4 83.1 ± 35.3 0.51 Mental health 80.9 ± 15.7 79.4 ± 16.1 0.61 *The values are given as the mean and standard deviation. †The values are given as the number with the percentage in parentheses. ‡Fractures classified according to the AO/OTA classification. §A significant difference between groups. In the intramedullary nailing group, thirty-nine (63%) of the sixty-two patients had a total of forty-three complications. The mean numbers of complications per patient, irrespective of their severity, were similar in the two groups (plate fixation: 0.67, intramedullary nailing: 0.74; p = 0.65). In the nailing group, irritation occurred on the medial side in thirty-one patients and laterally in two patients (one patient in this group underwent conversion to plate fixation and had irritation from the plate). In the plate-fixation group, five additional patients had the plate removed at their explicit request following fracture union. Also, two patients in the nailing group had the intramedullary device routinely removed under local anesthesia and ten had it 618 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d removed under general anesthesia to prevent future migration of the implant according to the treating surgeon’s practice. Discussion o significant difference in the primary study end parameter (the DASH score at six months postoperatively) was noted between the two surgical interventions. However, plate fixation resulted in more rapid improvement in the DASH score during the first six months after surgery. The complications were mainly implant-related and, in total, similar between the groups. The nailing group had slightly fewer complications requiring major revision. The DASH and CM scores at the time of final follow-up were comparable with previously reported values following plate1,5,17 and intramedullary4,17,18 fixation. We further assessed the level of physical function between six weeks and six months and demonstrated that plate fixation led to better subjective function in that period. In general, the frequency of postoperative complications was similar between the interventions. Medial protrusion of the titanium elastic nails was, however, a considerable problem, as it has been in previous studies19,20. Since the medial end of the titanium elastic nail cannot be locked, secondary shortening or rotation of the clavicle can result in protrusion of the nail. A possible solution for medial protrusion is the use of an end cap, which can be placed over the medial end of the titanium elastic nail19. In addition, we performed antegrade intramedullary fixation. Perhaps retrograde intramedullary nails and use of implants that are less prominent may reduce the prevalence of (medial) protrusion21,22. Lateral protrusion occurred only when the lateral cortex was penetrated accidentally during the operation. In addition, the study protocol did not include routine nail removal following fracture union. The interhospital and intersurgeon variation of participating centers in dealing with implant removal also in large part explains the high frequency of implant irritation in the nailing group. Care was taken to record symptoms of implant irritation after both interventions, but this does not provide a valid explanation for the high frequency of plate irritation encountered, especially when compared with previously reported data1,5. Placement of the plate on the anteroinferior aspect of the clavicle may be a solution to reduce implant irritation, but this may influence the strength of the repair construct and fracture-healing as a result of stripping of the muscular insertion23. The previously appreciated and biomechanically confirmed risk of refracture following plate removal was also illustrated in this study9,24. This finding stresses the importance of leaving plate-and-screw constructs in situ as long as possible and cautioning patients to avoid high-risk activities during the first months following removal. The durations of both surgical procedures were similar to previously reported values18,25. However, the number of open reductions in the intramedullary nailing group is remarkable considering that one of the advocated advantages of this antegrade technique is closed reduction. A clear explanation for this high rate of open reduction could not be found. All conversions from intramedullary nailing to plate fixation involved fractures located in the lateral part of the middle of the clavicular shaft. Even when the N P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D smallest-diameter nails were used, the lateral fragment of the clavicle could not be entered. This raises the question of the suitability of these fracture types for antegrade intramedullary fixation. The high rate of open reduction may explain the similarity between intervention groups in terms of the patients’ satisfaction with the cosmetic result. The one crossover in the plate group was the result of a communication error about trial randomization. Recent study results indicate that patients reach a steady state of shoulder function one year after surgery26. The present study showed similar levels of function at six months and one year after surgery. The strengths of this study include prospective randomization, power calculation, and the reporting of both objective and subjective outcomes scores with sufficient follow-up. In addition, care was taken throughout the follow-up process to note complications and describe them in detail. Several limitations also need to be addressed. The first limitation is inherent to the study’s multicenter and thus multisurgeon design, which may lead to variations in and possibly unpredictable results. We believe, however, that this reflects daily clinical practice in average hospitals and the results are therefore representative as an effectiveness trial design. Second, because of the differences in surgical techniques, neither the patients nor the treating surgeons could be blinded to the treatment group. In addition, all preoperative and postoperative data were collected by two investigators (F.-J.G.W. and M.H.) who were also not blinded. However, the use of a self-administered outcome questionnaire that was always completed prior to the actual follow-up appointment limited possible investigator-related bias. Furthermore, collecting DASH baseline scores was not planned in the original study protocol, disabling correction for remaining differences between study groups after randomization. In contrast, the SF-36 scores were collected at baseline and showed that the plate-fixation group was less vital than the intramedullary nailing group. The larger gain in vitality scores in the plate group at six and twelve months may have resulted from regression to the mean and should be interpreted with caution. The greater improvement in bodily pain scores in the plate group between baseline and six months after surgery should be assessed with the same caution as no significant difference between the study groups was observed in a secondary analysis comparing the six and twelve-month SF-36 subscales scores without correction for baseline. We suggest suspending judgment concerning possible differences in bodily pain and vitality between the groups as additional study is needed. Because we performed our analysis according to the intention-to-treat principle, one of the major revisions in the nailing group was actually of a plate in a patient who had undergone intraoperative conversion. However, the influence on the final outcome score was minimal. Finally, study inclusion was not discussed with forty-four potential participants because the attending surgeons did not have the experience with either procedure that was required by the study protocol. A retrospective comparison showed that the characteristics of these excluded patients, such as age and fracture pattern, were similar to those of the included patients. 619 TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015 d d d In conclusion, both procedures showed satisfying functional results, but plate fixation led to a faster recovery in the first six months after surgery. The rate of major complications in the plate-fixation group was slightly higher than that in the nailing group. In both groups, the main complication was implantrelated irritation. Future research should focus on determining which fixation type is appropriate for which fracture pattern. Appendix Tables showing intraoperative findings in each procedure group, improvement in SF-36 subscale scores compared with baseline, and postoperative complications after plate fixation and intramedullary fixation are available with the online version of this article as a data supplement at jbjs.org. n P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N M I D S H A F T C L AV I C U L A R F R A C T U R E S ? FOR D I S L O C AT E D Egbert J.M.M. Verleisdonk, MD, PhD Department of Surgery, Diakonessenhuis Utrecht, P.O. Box 80250, 3508 TG Utrecht, the Netherlands. E-mail address for E.J.M.M. Verleisdonk: [email protected] Marcel G.W. Dijkgraaf, PhD Clinical Research Unit, Academic Medical Center Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands Sven A.G. Meylaerts, MD, PhD Department of Surgery, Medical Center Haaglanden, P.O. Box 432, 2501 CK The Hague, the Netherlands Eric R. Hammacher, MD, PhD Department of Surgery, St. Antonius Hospital, P.O. Box 2500, 3430 EM Nieuwegein, the Netherlands Michiel H.J. Verhofstad, MD, PhD Department of Surgery, Erasmus Medical Center, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands Olivier A. van der Meijden, MD, PhD R. Marijn Houwert, MD, PhD Martijn Hulsmans, MD Frans-Jasper G. Wijdicks, MD, PhD References 1. Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. 2. McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40. 3. Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br. 1998 May;80(3):476-84. 4. Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized, controlled, clinical trial. J Orthop Trauma. 2009 Feb;23(2):106-12. 5. Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, Foster CJ, Clark K, Brooksbank AJ, Arthur A, Crowther MA, Packham I, Chesser TJ. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. 6. Lenza M, Belloti JC, Gomes Dos Santos JB, Matsumoto MH, Faloppa F. Surgical interventions for treating acute fractures or non-union of the middle third of the clavicle. Cochrane Database Syst Rev. 2009;7(4):CD007428. Epub 2009 Oct 7. 7. Drosdowech DS, Manwell SE, Ferreira LM, Goel DP, Faber KJ, Johnson JA. Biomechanical analysis of fixation of middle third fractures of the clavicle. J Orthop Trauma. 2011 Jan;25(1):39-43. 8. Renfree T, Conrad B, Wright T. Biomechanical comparison of contemporary clavicle fixation devices. J Hand Surg Am. 2010 Apr;35(4):639-44. 9. Wijdicks FJ, Van der Meijden OA, Millett PJ, Verleisdonk EJ, Houwert RM. Systematic review of the complications of plate fixation of clavicle fractures. Arch Orthop Trauma Surg. 2012 May;132(5):617-25. Epub 2012 Jan 10. 10. Wijdicks FJ, Houwert RM, Millett PJ, Verleisdonk EJ, Van der Meijden OA. Systematic review of complications after intramedullary fixation for displaced midshaft clavicle fractures. Can J Surg. 2013 Feb;56(1):58-64. 11. Wijdicks FJG, Houwert RM, Dijkgraaf MGW, De Lange DH, Meylaerts SAG, Verhofstad MHJ, Verleisdonk EJM. Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial. Trials. 2011;12:177. Epub 2011 Jul 15. 12. World Medical Association. WMA Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/ 30publications/10policies/b3/index.html. Accessed 2015 Jan 12. 13. Hudak PL, Amadio PC, Bombardier C; The Upper Extremity Collaborative Group (UECG). Development of an upper extremity outcome measure: the DASH (Disabilities of the Arm, Shoulder and Hand) [corrected]. Am J Ind Med. 1996 Jun;29(6): 602-8. 14. Gummesson C, Atroshi I, Ekdahl C. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16; 4:11. Epub 2003 Jun 16. 15. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;214:160-4. 16. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998 Nov;51(11):1055-68. 17. Ferran NA, Hodgson P, Vannet N, Williams R, Evans RO. Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: a randomized clinical trial. J Shoulder Elbow Surg. 2010 Sep;19(6):783-9. 18. Assobhi JEH. Reconstruction plate versus minimal invasive retrograde titanium elastic nail fixation for displaced midclavicular fractures. J Orthop Traumatol. 2011 Dec;12(4):185-92. Epub 2011 Sep 27. 19. Frigg A, Rillmann P, Perren T, Gerber M, Ryf C. Intramedullary nailing of clavicular midshaft fractures with the titanium elastic nail: problems and complications. Am J Sports Med. 2009 Feb;37(2):352-9. Epub 2008 Dec 31. 20. Wijdicks FJ, Houwert M, Dijkgraaf M, de Lange D, Oosterhuis K, Clevers G, Verleisdonk EJ. Complications after plate fixation and elastic stable intramedullary nailing of dislocated midshaft clavicle fractures: a retrospective comparison. Int Orthop. 2012 Oct;36(10):2139-45. Epub 2012 Jul 31. 21. Millett PJ, Hurst JM, Horan MP, Hawkins RJ. Complications of clavicle fractures treated with intramedullary fixation. J Shoulder Elbow Surg. 2011 Jan;20(1):86-91. Epub 2010 Nov 3. 22. King PR, Ikram A, Lamberts RP. The treatment of clavicular shaft fractures with an innovative locked intramedullary device. J Shoulder Elbow Surg. 2015 Jan;24(1): e1-6. Epub 2014 Jun 18. 23. Iannotti MR, Crosby LA, Stafford P, Grayson G, Goulet R. Effects of plate location and selection on the stability of midshaft clavicle osteotomies: a biomechanical study. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):457-62. 24. Smith SD, Wijdicks CA, Jansson KS, Boykin RE, Martetschlaeger F, de Meijer PP, Millett PJ, Hackett TR. Stability of mid-shaft clavicle fractures after plate fixation versus intramedullary repair and after hardware removal. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):448-55. Epub 2013 Jan 31. 25. B¨ohme J, Bonk A, Bacher GO, Wilharm A, Hoffmann R, Josten C. [Current treatment concepts for mid-shaft fractures of the clavicle - results of a prospective multicentre study]. Z Orthop Unfall. 2011 Jan;149(1):68-76. Epub 2010 Oct 12. German. 26. Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function plateaus by one year in patients with surgically treated displaced midshaft clavicle fractures. Clin Orthop Relat Res. 2011 Dec;469(12):3351-5.
© Copyright 2024