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Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418


Bone & Joint Open
Vol. 2, Issue 4 | Pages 227 - 235
1 Apr 2021
Makaram NS Leow JM Clement ND Oliver WM Ng ZH Simpson C Keating JF

Aims. The primary aim of this study was to identify independent predictors associated with nonunion and delayed union of tibial diaphyseal fractures treated with intramedullary nailing. The secondary aim was to assess the Radiological Union Scale for Tibial fractures (RUST) score as an early predictor of tibial fracture nonunion. Methods. A consecutive series of 647 patients who underwent intramedullary nailing for tibial diaphyseal fractures were identified from a trauma database. Demographic data, comorbidities, smoking status, alcohol consumption, use of non-steroidal anti-inflammatory drugs (NSAIDs), and steroid use were documented. Details regarding mechanism of injury, fracture classification, complications, and further surgery were recorded. Nonunion was defined as the requirement for revision surgery to achieve union. Delayed union was defined as a RUST score < 10 at six months postoperatively. Results. There were 41 nonunions (6.3%), of which 13 were infected (31.7%), and 77 delayed unions (11.9%). There were 127 open fractures (19.6%). Adjusting for confounding variables, NSAID use (odds ratio (OR) 3.50; p = 0.042), superficial infection (OR 3.00; p = 0.026), open fractures (OR 5.44; p < 0.001), and high-energy mechanism (OR 2.51; p = 0.040) were independently associated with nonunion. Smoking (OR 1.76; p = 0.034), open fracture (OR 2.82; p = 0.001), and high-energy mechanism (OR 1.81; p = 0.030) were independent predictors associated with delayed union. The RUST score at six-week follow-up was highly predictive of nonunion (sensitivity and specificity of 75%). Conclusion. NSAID use, high-energy mechanisms, open fractures, and superficial infection were independently associated with nonunion in patients with tibial diaphyseal fractures treated with intramedullary nailing. The six-week RUST score may be useful in identifying patients at risk of nonunion. Cite this article: Bone Jt Open 2021;2(4):227–235


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_4 | Pages 8 - 8
1 May 2015
Tsang S Mills L Frantzias J Baren J Keating J Simpson A
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The aim of this study was to identify risk factors for failure of exchange nailing for femoral diaphyseal fracture non-unions. The study cohort comprised 40 patients with femoral diaphyseal non-unions treated by exchange nailing. The main outcome measures were union, number of secondary fixation procedures required to achieve union and time to union. Univariate analysis and multiple regression were used to identify risk factors for failure to achieve union. The mean age of the patients at exchange nail surgery was 37 years. The median time to exchange nailing from primary fixation was 8.4 months. Multiple causes for non-union were found in 14 (35.0%) cases, with infection present in 12 (30.0%) patients. Further exchange procedures were required in nine (22.5%) cases, one patient (2.5%) required the use of another fixation modality, to achieve union. Union was ultimately achieved in 35 (94.5%) patients. The median time to union was 9.4 months after the exchange nail procedure. Univariate analysis confirmed that cigarette smoking and infection were predictive of failure (p<0.05). Multi-regression analysis found that Gustilo-Anderson grade, presence of dead bone or a gap and infection were predictive of exchange nail failure (p <0.05). Exchange nailing is an effective treatment for aseptic femoral diaphyseal fracture non-union. Patients with infection required more than one procedure. Smoking, infection and the presence of dead-bone or a gap at the fracture site were associated with an increased risk of further fixation surgery


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 19 - 19
1 Dec 2017
Mediouni M Ziou D Cabana F
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With the advancement of the virtual technologies, three-dimensional surgical simulators are now possible. In this article, we describe an immersive simulation platform, allowing students in orthopaedic surgery to learn how to deal with a sample diaphyseal fracture of the femur using LC-DCP plate hole, cortical screw and verbrugge forceps. To reach certain realism, weight of the objects and force feedback are used in addition to the visual scene and the 3D sound. The students feel the weight, the strength of the bone when they pierce the holes, and the vibration of the drill. The simulation is implemented by using CAVE, the CyberGlove, CyberGrasp, and 3D sound system


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_14 | Pages 1 - 1
1 Oct 2014
Tsang S Mills L Frantzias J Baren J Keating J Simpson A
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The aim of this study was to identify risk factors for failure of exchange nailing in tibial diaphyseal fracture non-unions. The cohort comprised 99 tibial diaphyseal fracture non-unions treated by exchange nailing. The mean age of the patients at exchange nail surgery was 36 years. The median time from primary fixation to exchange nailing was 6.4 months. The main outcome measures were union, number of secondary fixation procedures required to achieve union and time to union. Univariate analysis and multiple regression were used to identify risk factors for failure to achieve union. Multiple causes for non-union were found in 31.3% cases, with infection present in 32.3%. Further exchange procedures were required in 35.4%, 7.1% required the use of other fixation modalities. Union was ultimately achieved in 97.8%. The median time to union was 8.7 months. Univariate analysis revealed that cigarette smoking, an atrophic pattern of non-union and infection were predictive for failure of exchange nailing (p<0.05). Multi-regression analysis found that only infection was statistically significantly predictive (p<0.05) of exchange nail failure. Exchange nailing is an effective treatment for tibial diaphyseal non-unions even in the presence of infection. Smoking, atrophic pattern of non-union and infection are associated with an increased risk of further fixation surgery


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 563 - 567
1 Apr 2013
İltar S Alemdaroğlu KB Say F Aydoğan NH

Redisplacement is the most common complication of immobilisation in a cast for the treatment of diaphyseal fractures of the forearm in children. We have previously shown that the three-point index (TPI) can accurately predict redisplacement of fractures of the distal radius. In this prospective study we applied this index to assessment of diaphyseal fractures of the forearm in children and compared it with other cast-related indices that might predict redisplacement. A total of 76 children were included. Their ages, initial displacement, quality of reduction, site and level of the fractures and quality of the casting according to the TPI, Canterbury index and padding index were analysed. Logistic regression analysis was used to investigate risk factors for redisplacement. A total of 18 fractures (24%) redisplaced in the cast. A TPI value of > 0.8 was the only significant risk factor for redisplacement (odds ratio 238.5 (95% confidence interval 7.063 to 8054.86); p < 0.001). The TPI was far superior to other radiological indices, with a sensitivity of 84% and a specificity of 97% in successfully predicting redisplacement. We recommend it for routine use in the management of these fractures in children. Cite this article: Bone Joint J 2013;95-B:563–7


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_19 | Pages 5 - 5
1 Apr 2013
Kazzaz S Kumar P Mahapatra A
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Introduction. We retrospectively evaluated our five years' experience in using Expandable Fixion nail system in tibial diaphyseal fractures. Materials/Methods. Eighteen cases with closed tibial diaphyseal fracture were identified between January 2006 and January 2011, all treated successfully with Fixion intramedullary nail as a primary osteosynthesis device. Results. All patients were followed-up in our department until clinical and radiological fusion was achieved with a mean follow-up of 13 months (range 6–20 months). There was one asymptomatic delayed union at 13 months, treated with regular observation until fusion was achieved. There was no incidence of infection, compartment syndrome or non-union in this group. Conclusion. We conclude from our experience that Expandable Fixion Nail is as effective as traditional locking intramedullary nail system in treating closed tibial shaft fracture with the advantages of shorter theatre time and less radiation exposure


Bone & Joint Open
Vol. 3, Issue 3 | Pages 236 - 244
14 Mar 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

Aims. The primary aim of this study was to determine the rates of return to work (RTW) and sport (RTS) following a humeral shaft fracture. The secondary aim was to identify factors independently associated with failure to RTW or RTS. Methods. From 2008 to 2017, all patients with a humeral diaphyseal fracture were retrospectively identified. Patient demographics and injury characteristics were recorded. Details of pre-injury employment, sporting participation, and levels of return post-injury were obtained via postal questionnaire. The University of California, Los Angeles (UCLA) Activity Scale was used to quantify physical activity among active patients. Regression was used to determine factors independently associated with failure to RTW or RTS. Results. The Work Group comprised 177 patients in employment prior to injury (mean age 47 years (17 to 78); 51% female (n = 90)). Mean follow-up was 5.8 years (1.3 to 11). Overall, 85% (n = 151) returned to work at a mean of 14 weeks post-injury (0 to 104), but only 60% (n = 106) returned full-time to their previous employment. Proximal-third fractures (adjusted odds ratio (aOR) 4.0 (95% confidence interval (CI) 1.2 to 14.2); p = 0.029) were independently associated with failure to RTW. The Sport Group comprised 182 patients involved in sport prior to injury (mean age 52 years (18 to 85); 57% female (n = 104)). Mean follow-up was 5.4 years (1.3 to 11). The mean UCLA score reduced from 6.9 (95% CI 6.6 to 7.2) before injury to 6.1 (95% CI 5.8 to 6.4) post-injury (p < 0.001). There were 89% (n = 162) who returned to sport: 8% (n = 14) within three months, 34% (n = 62) within six months, and 70% (n = 127) within one year. Age ≥ 60 years was independently associated with failure to RTS (aOR 3.0 (95% CI 1.1 to 8.2); p = 0.036). No other factors were independently associated with failure to RTW or RTS. Conclusion. Most patients successfully return to work and sport following a humeral shaft fracture, albeit at a lower level of physical activity. Patients aged ≥ 60 yrs and those with proximal-third diaphyseal fractures are at increased risk of failing to return to activity. Cite this article: Bone Jt Open 2022;3(3):236–244


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 6 | Pages 867 - 871
1 Aug 2000
Ring D Jupiter JB Quintero J Sanders RA Marti RK

We treated 15 patients with atrophic nonunion of a diaphyseal fracture of the humerus with an associated bony defect using an autogenous cancellous bone graft and a plate to bridge the defect. There were nine men and six women with a mean age of 48 years. The mean length of the bony defect was 3 cm. At a mean follow-up of 30 months only one fracture failed to unite. This suggests that, in the presence of a well-vascularised envelope of muscle, the application of an autogenous cancellous bone graft in conjunction with a bridging plate represents a good alternative to more demanding surgical techniques


Bone & Joint 360
Vol. 13, Issue 5 | Pages 39 - 42
1 Oct 2024

The October 2024 Trauma Roundup. 360. looks at: Early versus delayed weightbearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomized controlled trial; The effect of early weightbearing and later weightbearing rehabilitation interventions on outcomes after ankle fracture surgery; Is intramedullary nailing of femoral diaphyseal fractures in the lateral decubitus position as safe and effective as on a traction table?; Periprosthetic fractures of the hip: Back to the Future, Groundhog Day, and horses for courses; Two big bones, one big decision: when to fix bilateral femur fractures; Comparison of ankle fracture fixation using intramedullary fibular nailing versus plate fixation; Unclassified acetabular fractures: do they really exist?


Bone & Joint 360
Vol. 13, Issue 6 | Pages 36 - 39
1 Dec 2024

The December 2024 Trauma Roundup. 360. looks at: Percutaneous lumbopelvic fixation is effective in the management of unstable transverse sacral fractures; A systematic review on autologous matrix-induced chondrogenesis (AMIC) for chondral knee defects; Stable clinical and radiological outcomes at medium and over five-year follow-up of calcaneus fracture open reduction internal fixation using a sinus tarsi approach; Right or left? It might make a difference; Suprapatellar versus infrapatellar tibial nailing – is there a difference in anterior knee pain and function?; Can patients safely weightbear following ankle fracture fixation?; Anterior-to-posterior or a plate fixation for posterior malleous fractures?; Audio distraction for traction pin insertion: a prospective randomized controlled study; Is intramedullary nailing of femoral diaphyseal fractures in the lateral decubitus position as safe and effective as on a traction table?


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 4 | Pages 581 - 584
1 May 2004
Myers GJC Gibbons PJ Glithero PR

We identified 25 children (10 girls and 15 boys) who had been treated with single bone intramedullary fixation for diaphyseal fractures of both forearm bones. Their mean age was 10.75 years (4.6 to 15.9). All had a good functional outcome. We conclude that in selected children, single bone intramedullary nailing is a suitable method of treatment for diaphyseal fractures of both bones of the forearm


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Aim

To review the patients that have undergone correction of a symptomatic femoral malunion using osteotomy combined with decortication.

Methods

A retrospective review of all patients who have undergone the procedure, looking at the pre-operative deformity, correction achieved, time to union and complications.


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We reviewed patients that have undergone correction of a symptomatic femoral malunion using osteotomy combined with decortication by retrospective reviewing all patients who have undergone the procedure, looking at the pre-operative deformity, correction achieved, time to union and complications.

Seven patients underwent correction under the senior author from 2003 to today. Average age was 46 years (range 32–60 years). All had femoral shortening, average 2.7cm (range 2–4 cm). Each also had at least one other plane of deformity with rotation being the next most commonly encountered in 5 out of the 7 (average 33 degrees). 2 had tri-planar deformity with the 5 having bi-planar deformity. Average time to union was 18.4 months (range 7 to 39 months) with an average of 1.6 operations (range 1 to 3 operations) to union. Two patients are awaiting union, 1 has required repeat plating and one is a primary fixation and correction awaiting union.

Correction of multiplanar deformity of the femur is challenging. Osteotomy with decortication provides a technique to achieve correction of significant femoral deformity union achieving full multi-planar deformity correction in a single operation. This paper provides guidance and a technical description of the operative technique.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 184 - 184
1 Sep 2012
Ralte P Grant S Withers D Walton R Morapudi S Bassi R Fischer J Waseem M
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Purpose. Plating remains the most widely employed method for the fixation of displaced diaphyseal clavicle fractures. The purpose of this study was to assess the efficacy and outcomes of diaphyseal clavicle fractures treated with intramedullary fixation using the Rockwood clavicle pin. Methods. We conducted a retrospective analysis of all diaphyseal clavicle fractures treated with intramedullary fixation using the Rockwood pin between February 2004 and March 2010. Sixty-eight procedures were carried out on 67 patients. Functional outcome was assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and an overall patient satisfaction questionnaire. Results. There were 52 (77.6%) male and 15 (22.4%) female patients with an average age of 35.8 years. In 35 (51.5%) cases the injury was located on the dominant side. Fractures were classified according to the Edinburgh system with the commonest configuration being the Type 2B1 (47, 69.1%). The indications for fixation were; acute management of displaced fractures (56, 82.4%), delayed union (2, 2.9%), nonunion (8, 11.8%) and malunion (2, 2.9%). The average time to pin removal was 3.7 months and the average follow-up prior to discharge was 6.9 months. Sixty-six (97.1%) fractures united without consequence. Two (2.9%) cases of non-union were treated with repeat fixation using a contoured plate and bone graft. The most common problem encountered postoperatively was discomfort due to subcutaneous pin prominence posteriorly (12, 17.6%) which resolved following removal of the metalwork. The average DASH score was 6.04 (0–60) and 96.4% of patients rated their satisfaction with the procedure as good to excellent. Conclusion. Due to its minimally invasive technique, cosmetically favourable scar, preservation of periosteal tissue, avoidance of stress risers associated with screw removal and good clinical outcomes, the use of this device is the preferred method of treatment for displaced diaphyseal clavicle fractures in our hospital


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 1 | Pages 91 - 94
1 Jan 1998
Yung SH Lam CY Choi KY Ng KW Maffulli N Cheng JCY

Displaced fractures of the forearm in children are often treated conservatively, but there is a relatively high incidence of redisplacement, malunion and consequent limitation of function. We have performed percutaneous Kirschner (K) wire fixation in 72 such children under the age of 14 years, of which 57 were reviewed for our study. Both the radius and ulna were fractured in 45 (79%), the radius only in eight and the ulna only in four. The mean initial angulation was 19° in the lateral plane and 9° in the anteroposterior plane for the radius and 15° and 9°, respectively, for the ulna. In 42 patients (74%) we performed closed reduction. In the remaining 15 (26%) closed reduction failed and an open reduction, through a minimal approach, was required before K wiring. At a mean follow-up of 20 months all patients had good functional results with an excellent range of movement. Only five had angulation of from 10° to 15° and none had nonunion, premature epiphyseal closure or deep infection. Percutaneous intramedullary K wiring for forearm diaphyseal fracture is a convenient, effective and safe operation, with minimal complications


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 108 - 108
1 Jan 2013
Patel A Anand A Alam M Anand B
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Background. Both-bone diaphyseal forearm fractures constitute up to 5.4% of all fractures in children under 16 years of age in the United Kingdom. Most can be managed with closed reduction and cast immobilisation. Surgical fixation options include flexible intramedullary nailing and plating. However, the optimal method is controversial. Objectives. The main purpose of this study was to systematically search for and critically appraise articles comparing functional outcomes, radiographic outcomes and complications of nailing and plating for both-bone diaphyseal forearm fractures in children. Methods. A literature search of MEDLINE (PubMed), EMBASE and Cochrane library databases using specific search terms and limits was undertaken. The critical appraisal checklist (adapted from Critical Appraisal Skills Programme-CASP, Oxford; Guyatt et al) for an article on treatment was used to aid assessment. Results. All 7 studies identified were retrospective, comparative and non-randomized. They all included patients with similar baseline characteristics. There were no statistically significant differences in group outcomes for range of forearm movement, time to fracture union and complication rates. Less operative time and better cosmesis was noted in the IM nailing groups. Some studies showed post-operative radial bow was significantly abnormal in the IM nailing groups, but did not affect forearm movement. Conclusion. Based on similar functional and radiographic outcomes, nailing seems to be a safe and effective option when compared to plating for forearm fractures in children. However, critical appraisal of the studies in this review identified some methodological deficiencies and further prospective, randomized trials are recommended


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 90 - 90
17 Apr 2023
Kale S Singh S Dhar S
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To evaluate the functional outcome of open humerus diaphyseal fractures treated with the Three-stitch technique of antegrade humerus nailing. This is a retrospective study conducted at the Department of Orthopaedics in D. Y. Patil University, School of Medicine, Navi Mumbai, India. The study included 25 patients who were operated on from January 2019 to April 2021 and follow-ups done till May 2022. Inclusion criteria were adult patients with open humerus diaphyseal fractures (Gustilo-Anderson Classification). All patients with closed fractures, skeletally immature patients, and patients with associated head injury were excluded from the study. All patients were operated on with a minimally invasive Three-stitch technique for antegrade humerus nailing. All patients were evaluated based on DASH score. Out of the 25 patients included in the study, all patients showed complete union. The mean age of the patients was 40.4 years (range 23–66 years). The average period for consolidation of fracture was 10.56 weeks (range 8–14 weeks). The DASH score ranged from 0 to 15.8 with an average score of 2.96. Five patients reported complications with three patients of post-operative infection and delayed wound healing and two patients with screw loosening. All complications were resolved with proper wound care and the complete union was noted. None of the patients had an iatrogenic neurovascular injury. Three-stitch antegrade nailing technique is a novel method to treat diaphyseal humerus fractures and provides excellent results. It has various advantages such as minimal invasiveness, minimal injury to the rotator cuff, fewer infection rates, minimal iatrogenic injuries, and good functional outcomes. Therefore, this treatment modality can be effectively used for open humerus diaphyseal fractures


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 928 - 934
1 Aug 2023
Amilon S Bergdahl C Fridh E Backteman T Ekelund J Wennergren D

Aims. The aim of this study was to describe the incidence of refractures among children, following fractures of all long bones, and to identify when the risk of refracture decreases. Methods. All patients aged under 16 years with a fracture that had occurred in a bone with ongoing growth (open physis) from 1 May 2015 to 31 December 2020 were retrieved from the Swedish Fracture Register. A new fracture in the same segment within one year of the primary fracture was regarded as a refracture. Fracture localization, sex, lateral distribution, and time from primary fracture to refracture were analyzed for all long bones. Results. Of 40,090 primary fractures, 348 children (0.88%) sustained a refracture in the same long bone segment. The diaphyseal forearm was the long bone segment most commonly affected by refractures (n = 140; 3.4%). The median time to refracture was 147 days (interquartile range 82 to 253) in all segments of the long bones combined. The majority of the refractures occurred in boys (n = 236; 67%), and the left side was the most common side to refracture (n = 220; 62%). The data in this study suggest that the risk of refracture decreases after 180 days in the diaphyseal forearm, after 90 days in the distal forearm, and after 135 days in the diaphyseal tibia. Conclusion. Refractures in children are rare. However, different fractured segments run a different threat of refracture, with the highest risk associated with diaphyseal forearm fractures. The data in this study imply that children who have sustained a distal forearm fracture should avoid hazardous activities for three months, while children with a diaphyseal forearm fracture should avoid these activities for six months, and for four and a half months if they have sustained a diaphyseal tibia fracture. Cite this article: Bone Joint J 2023;105-B(8):928–934


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 2 - 2
1 Dec 2022
Schneider P Bergeron S Liew A Kreder H Berry, G
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Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes. Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model. A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group. This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups