Project description:Fracture of the clavicle is common, accounting for 2.6 to 4.0 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80 % of clavicle fractures occur in the middle third of the clavicle. Randomised controlled trials comparing treatment interventions have failed to indicate the best therapeutic practices for these fractures. The objective of this study is to evaluate the effects (benefits and harms) of two commonly-used conservative interventions: the figure-of-eight bandage versus the arm sling as treatments of middle-third clavicle fractures.This project has been designed as a single-centre, two-arm randomised controlled trial that will compare two interventions: figure-of-eight bandage versus the arm sling. We propose to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days since injury) middle-third clavicle fracture. The primary outcomes to be evaluated will be function and/or disability measured by the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. In order to assess the secondary outcomes, the Modified University of California at Los Angeles (modified - UCLA) Shoulder Rating Scale will be used. The occurrence of pain (Visual Analogue Scale for pain (VAS)), treatment failure, adverse events and the ability to return to previous activities will also be recorded and evaluated as secondary outcomes.the primary outcome DASH score and the secondary outcomes - modified UCLA and VAS scores - will be analysed graphically. We will apply generalised mixed models with the intervention groups (two levels), and time-point assessments (seven levels) as fixed effects and patients as a random effect.According to the current literature there is very limited evidence from two small trials regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This is the first randomised controlled trial comparing the figure-of-eight bandage versus the arm sling for treating clavicle fractures that follows the CONSORT Statement guidelines.ClinicalTrials.gov NCT02398006 .
Project description:BACKGROUND:Isolated fractures of the shaft of the ulna, which are often sustained when the forearm is raised to shield against a blow, are generally treated on an outpatient basis. This is an update of a Cochrane review first published in 1998 and last updated in 2009. OBJECTIVES:To assess the effects of various forms of treatment for isolated fractures of the ulnar shaft in adults. SEARCH METHODS:We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2012, Issue 3), MEDLINE (1966 to April week 1 2012), EMBASE (1981 to week 15 2012), CINAHL (1982 to 16 April 2012), various trial registers, various conference proceedings and bibliographies of relevant articles. SELECTION CRITERIA:Randomised or quasi-randomised trials of conservative and surgical treatment of isolated fractures of the ulnar shaft in adults. Excluded were fractures of the proximal ulna and Monteggia fracture dislocations. DATA COLLECTION AND ANALYSIS:We performed independent assessment of risk of bias and data extraction. We contacted trialists for more information. There was no pooling of data. MAIN RESULTS:The updated search resulted in the identification of one ongoing trial comparing surgery versus conservative treatment.Four trials, involving a total of 237 participants, were included. All four trials were methodologically flawed and potentially biased.Three trials tested conservative treatment interventions. One trial, which compared short arm (below elbow) pre-fabricated functional braces with long arm (elbow included) plaster casts, found there was no significant difference in the time it took for fracture union. Patient satisfaction and return to work during treatment were significantly better in the brace group. The other two trials, both quasi-randomised, had three treatment groups. One trial compared Ace Wrap elastic bandage versus short arm plaster cast versus long arm plaster cast. The large loss to follow-up in this trial makes any data analysis tentative. However, the need for replacement of the Ace wrap by other methods due to pain indicates the potential for a serious problem with this intervention. The other trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no significant differences in outcome between these three interventions.The fourth trial, which compared two types of plates for surgical fixation, found no significant differences in functional or anatomical outcomes nor complications between the two groups. AUTHORS' CONCLUSIONS:There is insufficient evidence from randomised trials to determine which method of treatment is the most appropriate for isolated fractures of the ulnar shaft in adults. Well designed and reported randomised trials of current forms of conservative treatment are recommended.
Project description:Background and purposeTraditionally, clavicle fractures have been treated nonoperatively. However, many recent studies have concentrated on the results of operative treatment. We assessed and compared the outcomes of operative and nonoperative treatment for acute clavicle fractures in adults.MethodsWe performed a systematic search of the medical literature from 1966 until the end of March 2011. We included randomized controlled trials and controlled clinical trials comparing operative and nonoperative treatment and studies comparing different operative and nonoperative treatments. We required that there should be at least 30 adult patients and a follow-up of at least 6 months in each individual trial. We used the GRADE method to assess the quality of evidence.Results6 randomized controlled trials (n = 631) and 7 controlled clinical trials (n = 559) were included. There was moderate-quality evidence (i.e. of grade B) (1) that surgery has considerable effectiveness on better function and less disability at short follow-up, (2) of similar risk of relatively mild complications after operative or nonoperative treatment, (3) that delayed union and nonunion were more common in patients who were treated nonoperatively than in those treated operatively, and (4) that the osteosynthesis method had no effect on the incidence of delayed union or nonunion. Only 1 controlled clinical trial was found on lateral clavicle fractures with very limited (grade D) evidence.InterpretationPatients treated operatively have slightly better function and less disability than those treated nonoperatively at short follow-up, but then the effectiveness diminishes and is weak at 6 months. The different operative techniques may not differ in effectiveness or in adverse effects, but the evidence is very limited or conflicting. Surgery could be considered for active patients who require recovery to the previous level of activity in the shortest possible time.
Project description:We retrospectively assessed the union and shoulder function following hook plate fixation in 18 patients with Neer type 2 fractures of the lateral end of the clavicle. The average age was 40 (range 22-62) years, and the mean follow-up was 25 (range 6-48) months. Fifteen patients had acute fractures and the rest were non-unions. Complications included two non-unions, one following a deep infection. There were no iatrogenic fractures. Acromial osteolysis was seen in five patients who had their plates in situ. The average pain score at rest was 1 (range 0-4), and the average pain score on abduction was 2.2 (range 0-5). The average Constant score was 88.5 (range 63-100). Patients were asked to rate their shoulder function; three rated it as normal, 11 as nearly normal and one as not normal. Hook plate fixation appears to be a valuable method of stabilising Neer type 2 fractures of the clavicle, resulting in high union rates and good shoulder function. These plates need to be removed after union to prevent acromial osteolysis.
Project description:Surgical treatment is usually indicated for the management of Neer type IIB fractures of the distal third of the clavicle. These unstable injuries have shown a rate of nonunion that oscillates around 30% to 45% when managed conservatively, and surgical strategies often require a second operation for implant removal. We describe an arthroscopic-assisted technique for the treatment of Neer type IIB unstable distal-third clavicle fractures that overcomes the issues related to open surgery, metal hardware, and implant irritation. This technique increases the load to failure of the construct by means of adding a synthetic conoid ligament reconstruction with a nonrigid suspension device, and it allows the diagnosis and treatment of associated glenohumeral injuries. Our technique incorporates a fracture interfragmentary fixation with sutures, thus avoiding a second operation for implant removal.
Project description:BackgroundThe popularity of surgery for acute displaced midshaft clavicle fractures has been fuelled by early randomized controlled trials (RCTs) showing improved rates of radiographic union and perceived functional benefits compared with nonoperative approaches. We performed a meta-analysis to determine the effect of operative and nonoperative interventions on the risk of secondary operation and complications and on long-term function.MethodsWe search MEDLINE, Embase and the Cochrane Central Register of Controlled Trials for reports of relevant RCTs published to Mar. 7, 2014. Two reviewers assessed eligibility of potential reports and the risk of bias of included trials. The Grading of Recommendations Assessment, Development and Evaluation approach was used to summarize the quality of evidence for all outcomes.ResultsWe included 15 RCTs (9 trials comparing operative and nonoperative interventions, 5 comparing implants for operative treatment, and 1 comparing nonoperative treatments). Nonoperative treatments did not differ from operative treatments in the risk of secondary operation (risk ratio [RR] 1.16, 95% confidence interval [CI] 0.58 to 2.35) or all complications (RR 0.90, 95% CI 0.55 to 1.50). One in 4 patients had a complication regardless of the treatment approach. Differences in functional outcomes, although smaller than the threshold for minimal important differences at 1 year, favoured operative interventions (standardized mean difference 0.38, 95% CI 0 to 0.75). Evidence for the type of implant or approach to nonoperative treatment remained inconclusive.InterpretationCurrent evidence does not support the routine use of internal fixation for the treatment of displaced midshaft clavicle fractures. Complication rates were high regardless of the treatment approach.
Project description:Clavicle fractures comprise approximately 3% of all adult fractures and there is evidence that the incidence is increasing. Fractures of the lateral and middle third of the clavicle present distinct challenges in both surgical fixation techniques and clinical outcome, as such they should be recognised as separate clinical entities. Despite conflicting evidence, most studies indicate that superior clinical results are found in patients with united clavicle fractures rather than those that go onto non-union. Furthermore there is level-1 evidence that operative treatment of clavicle fractures leads to significantly increased rates of union. Despite these findings, significant controversy still exists on which patients would benefit from primary fixation and those who could successfully be managed non-operatively. We present an evidence-based review of clavicle fracture management including surgical indications, techniques, and results.