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Long-term outcome following additional rhBMP-7 application in revision surgery of aseptic humeral, femoral, and tibial shaft nonunion.

ABSTRACT: Surgical revision concepts for the treatment of aseptic humeral, femoral, and tibial diaphyseal nonunion were evaluated. It was analyzed if the range of time to bone healing was shorter, and if clinical and radiological long-term outcome was better following application of additional recombinant human Bone Morphogenetic Protein-7 (rhBMP-7) compared to no additional rhBMP-7 use.In a retrospective comparative study between 06/2006 and 05/2013, 112 patients diagnosed with aseptic diaphyseal humerus (22 patients), femur (41 patients), and tibia (49 patients) nonunion were treated using internal fixation and bone graft augmentation. For additional stimulation of bone healing, growth factor rhBMP-7 was locally administered in 62 out of 112 patients. Follow-up studies including clinical and radiological assessment were performed at regular intervals as well as after at least one year following nonunion surgery.One hundred and two out of 112 (humerus: 19, femur: 37, tibia: 47) nonunion healed within 12 months after revision surgery without any significant differences between the cohort groups. According to the DASH outcome measure for the humerus (p = 0.679), LEFS for the femur (p = 0.251) and the tibia (p = 0.946) as well as to the SF-12 for all entities, no significant differences between the treatment groups were found.Aseptic diaphyseal nonunion in humerus, femur, and tibia healed irrespectively of additional rhBMP-7 application. Moreover, the results of this study suggest that successful nonunion healing can be linked to precise surgical concepts using radical removal of nonunion tissue, stable fixation and restoration of axis, length and torsion, rather than to the additional use of signaling proteins.This clinical trial was conducted according to ICMJE guidelines as well as to the approval of the National Medical Board (Ethics Committee of the Bavarian State Chamber of Physicians; TRN: 2016-104) and has been retrospectively registered with the German Clinical Trails Register (TRN: DRKS00012652 ).

SUBMITTER: Hackl S

PROVIDER: S-EPMC5547494 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

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Project description:BACKGROUND:Although most humeral nonunions are successfully treated with a single procedure, some humeral nonunions are more difficult to heal and require multiple procedures. Current literature does not provide evidence describing how the prognosis for surgical repair in patients who develop humeral diaphyseal nonunions may be affected by initial operative versus nonoperative treatment. QUESTIONS/PURPOSES:The purpose of this study was to assess whether operative versus nonoperative treatment of acute humeral shaft fractures impacts outcome of subsequent repairs of humeral nonunions (NU) including the need for additional surgery and a comparison of pain relief (Visual Analogue Scale for pain) and functional outcome (Short Musculoskeletal Functional Assessment). METHODS:Thirty-four patients with humeral shaft nonunion were evaluated of which 15 patients had been treated operatively (OF), and 19 patients had been treated nonoperatively (NO) for their initial humerus shaft fracture. All patients underwent plating with autogenous bone graft or allograft ± bone morphogenic protein (BMP) 2 or 7 as their final NU repair surgery prior to healing. We compared functional outcome and pain for both cohorts and determined risk factors for requiring more than 1 nonunion repair surgery. RESULTS:The mean time of final follow-up was 14.7?±?10.4 months. Thirty-three of 34 NUs (97.1%) healed. Patients who underwent OF of their original fracture were more likely to require more than 1 NU repair surgery (66.7 vs. 0%, p?<?0.01). Of the 15 patients who underwent initial OF, 33.0% required 1 NU surgery, 33.0% required 2 NU surgeries, and 33.0% required 3 NU surgeries. Patients who underwent initial OF were more likely to require >6 months to achieve union (40.0 vs. 10.5%, p?=?0.04). At final follow-up, there was no difference in functional outcome or pain scores. Initial OF was the only independent predictor of needing more than 1 NU repair surgery (OR 70.1 CI 2.8-1762.3) to achieve healing. CONCLUSION:Humeral shaft nonunions following initial operative fixation of the index fracture is more resistant to achieving union when compared to nonunions forming after initial nonoperative treatment. When final healing is achieved, there is no difference in function or pain.

Project description:ImportanceHumeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.ObjectiveTo compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.Design, setting, and participantsRandomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.InterventionsPatients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).Main outcome and measureThe primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).ResultsAmong 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.Conclusions and relevanceAmong patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.Trial registrationClinicalTrials.gov Identifier: NCT01719887.

Project description:BackgroundAlthough relatively rare, non-unions and mal-unions of tibial plateau fractures present significant challenges for the orthopedic surgeon. With careful pre-operative planning, tibial plateau mal-union or non-union revision surgery with intra-articular and varus opening osteotomies can provides good functional results when performed early (within 1 year) after primary surgical procedure.Questions/purposesWe present our treatment algorithm for approaching and treating non-union or mal-union of tibial plateau fractures. Our aim is to give surgeons treating these difficult injuries an overview of the pertinent literature as well as describe the challenges and pitfalls we have experienced when treating non-union or mal-union of tibial plateau fractures.MethodsUsing two case examples from our institution, one for mal-union and one for mal-reduction, we describe our treatment algorithm and surgical technique for managing these difficult injuries. We also provide a brief literature review outlining relevant studies and summarizing outcomes for similar injuries. A systematic literature review was conducted with the aim of determining the methods and outcomes commonly reported in the literature regarding revision surgery following tibial plateau non-union or mal-union. Due to the nature of revision surgery, there are no long-term randomized trials dealing with outcomes, but rather several smaller case series exist from which larger conclusions have to be drawn.ResultsTo date, we have successfully treated approximately 35 patients with this technique, and clinical follow-up continues to show good functional outcomes with reduced pain and little radiographic evidence of arthritic changes. Restoring long leg alignment, anatomic reduction of the articular surface, and achieving stable internal fixation are paramount in achieving the best long-term outcome. Due to the shallow soft tissue envelope around the proximal tibia, and the tendency for these fractures to fall into progressive valgus collapse, these problems can seem intimidating and complex. However, with well-planned surgery and meticulous surgical technique, reliable healing can be achieved.ConclusionBy outlining our method, we hope to provide other surgeons with an algorithm to guide clinical and operative decision making. These difficult injuries can be daunting to treat, but if performed before the onset of severe degenerative arthritis, early revision surgery, as we describe, can be a viable alternative to total knee arthroplasty, particularly in younger, more active patients.

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Long-term outcome following additional rhBMP-7 application in revision surgery of aseptic humeral, femoral, and tibial shaft nonunion.

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