Operative and Nonoperative Treatment of Humeral Shaft Fractures
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2009 | ||||
Last Updated Date | August 5, 2009 | ||||
Start Date ICMJE | August 2009 | ||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Validated functional outcome tools to be used: disability shoulder, arm, hand (DASH), short musculoskeletal functional assessment (SMFA) and Constant Shoulder Score. [ Time Frame: 2 and 6 weeks, 4, 6 and 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878319 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Operative and Nonoperative Treatment of Humeral Shaft Fractures | ||||
Official Title ICMJE | A Randomized Prospective Trial Comparing Operative and Nonoperative Treatment of Humeral Shaft Fractures | ||||
Brief Summary | The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal fixation (ORIF). The study will examine which treatment will overall give better results in regards to shoulder and elbow function, residual pain and deformity. Patients who agree to consent to participation in this study will be randomly selected to receive one of the two treatment methods:
Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will be arranged from the date of randomization. The patient will be asked to complete two questionnaires, reporting the level of wellbeing and physical function. These questionnaires will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4 months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete. At each appointment, the patients will be x-rayed until healing has occurred, examined and evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow and shoulder. |
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Detailed Description | Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Overall the incidence is higher in women and typically presents at a more advanced age in this population, rendering fixation more difficult due to osteoporosis. The majority of fractures of the humeral diaphysis occur in the mid-shaft and proximal third and the majority are simple (or non-comminuted) in pattern. Presently, the standard treatment of isolated humeral diaphysis fractures is nonoperative care using splints, braces, casts and slings. Most centres in North America and Europe favor functional bracing with a coaptation splint given the positive results reported with this device, despite the prolonged period of pain and discomfort as well as the need for repeated clinic follow-up visits associated with it. Presently there are no published prospective comparative studies that systematically evaluate patient function following the operative or nonoperative treatment of humeral shaft fractures. Clinical evaluations following functional bracing using patient-based outcome tools revealed a 20% nonunion rate in patients suffering a simple (non-comminuted) fracture. Invariably, this led to surgical intervention to achieve union. In those whose fracture healed with the splint, only 50% reported a full recovery while none of those requiring surgery for nonunion did so. This low rate of functional recovery may be due in part to the high rate of shoulder stiffness following functional bracing. Significant stiffness in the shoulder following functional bracing has ranged from 14-60% with an average of 40%. The advantages of open reduction and plate fixation of humeral shaft fractures include a direct approach to the fracture site with direct visualization and protection of the radial nerve (depending on fracture level and approach), the possibility of rigid compressive fixation, and the opportunity for bone grafting and/or radial nerve exploration if needed. Importantly, it permits rapid mobilization of the shoulder and elbow, obviating the need of immobilization, and ensures anatomic or near anatomic alignment. These advantages must be weighed against the small risk of infection (<1-6%) with most occurring after open fractures or severe crush injury, nonunion (4-6%) especially in high energy injuries, and iatrogenic radial nerve injury (1-3%) the vast majority of which are transient. Operative care: Fixation with regular or broad 3.5mm or 4.5mm dynamic compression plate (DCP) using standard technique will be applied in cases with normal bone density; in the face of osteopenic bone, locked-plate implants will be employed at the discretion of the surgeon. Bone graft will not be used routinely as these are simple fracture patterns. Postoperative splinting (or sling) will be maintained for 10 - 14 days followed by gentle ROM exercises under physiotherapy supervision. Strengthening and proprioception will be begun once fracture healing has occurred, typically at 6-8 weeks. Conservative care will entail the application of a plaster sugartong splint for 10-14 days followed by transition to a functional (coaptation) brace, to be applied by a qualified orthotist. Gentle ROM exercises of the elbow and shoulder will begin as tolerated under the supervision of a physiotherapist after 2 weeks with strengthening and proprioception added once fracture healing has occurred, typically at 6-8 weeks. This multicentre prospective randomized trial will involve the Canadian Orthopaedic Trauma Society (COTS), an association of trauma surgeons involved in collaborative outcomes research with a proven track record of research and publication. Patients with a humeral diaphyseal fracture who meet all eligibility criteria and provide consent to participate will be randomly assigned to the operative or splint/brace treatment group. Patients will start physiotherapy at 2 weeks post-randomization (splint/brace group)or 2 weeks post-surgery for gentle ROM exercises. The operative group will progress to strengthening and proprioception at 4-6 weeks. The splint/brace group will only progress at the 6-8 weeks mark once union has occurred. Evaluation at 2 and 6 weeks, 4, 6, and 12 months will include functional, clinical and radiological parameters. Functional evaluation will include the DASH, SMFA questionnaires and the Constant Shoulder Score. Clinical outcome will evaluate range and motion including the shoulder and elbow of both the affected arm and contralateral shoulder and elbow. Standard radiographic parameters will be measured. The primary outcome measure will be functional outcome as measured with the DASH. Appropriate statistical analyses will be performed on the data. Sample size calculation reveals the need for 90 patients per treatment arm. A census of the centers committed to the study predicts a 1-24 month recruitment period. Patient follow-up will end at the 12 month visit. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Humeral Mid-shaft Fractures | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 180 | ||||
Estimated Completion Date | May 2012 | ||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 90 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878319 | ||||
Other Study ID Numbers ICMJE | SDR-08-055 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Gregory K. Berry MDCM FRCSC, McGill University Health Centre | ||||
Study Sponsor ICMJE | McGill University Health Center | ||||
Collaborators ICMJE | Canadian Orthopaedic Trauma Society | ||||
Investigators ICMJE |
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Information Provided By | McGill University Health Center | ||||
Verification Date | August 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |