Distal Radius Fractures Clinical Trial
Official title:
The Fixation of Unstable Metaphyseal Distal Radius Fractures: A Randomized, Controlled Trial
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Wrist fractures are the most common type of fractures that occur in the shoulder, arm, and hand. Approximately 250,000 to 300,000 wrist fractures occur in the United States each year. Although some wrist fractures can be treated using casts, many other fractures must be treated with surgery. The surgery involves using metal plates and screws to put the broken pieces of bone together so that they can heal. The purpose of this study is to compare two specific types of surgery that are used to treat broken wrists. One type uses pieces of metal that are placed on the outside of the broken pieces of bone that are screwed in place while the broken bones heal. The other type of surgery involves placing a piece of metal inside the bone marrow to hold the broken pieces of bone together as they heal. Individuals with broken wrists who participate in this study will be randomly assigned to receive one of the two types of surgical treatment. Both surgical treatments are approved and are not experimental. Study participants will be followed closely after surgery to determine the time required for them to return to their usual daily activities involving the use of their arms and hands. Although both groups of study participants are expected to experience the same outcomes at one year, those participants that receive the device placed inside the bone marrow may return to their normal functional activities earlier than the ones treated with the plate placed on the outside of the bone. Study participants and their surgeons will complete data sheets and questionnaires that will document their progress following treatment of their wrist fractures.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients eligible for participation in this study will include skeletally mature individuals between the ages of 18 through 80 who have sustained closed, displaced, unstable, metaphyseal fractures of the distal radius requiring surgical fixation. Exclusion Criteria: - Patients ineligible for study participation will include: - patients with multitrauma who must be treated in the ICU for long periods of time - patients with open wrist fractures, - patients who are skeletally immature, - patients with concomitant scaphoid fractures or other hand injuries that impact functional recovery, - patients with bilateral arm fractures or comminuted intraarticular distal radius fractures, - patients who have sustained previous wrist injury of the affected arm, - signs of rheumatoid arthritis, osteoarthritis, or polyarthritis, and - patients with physical or mental issues that make obtaining informed consent impossible. - Any comorbid health conditions of the study participants (e.g. high blood pressure, COPD) will be documented. - Patients who are interested in participating in this study will be asked to provide informed consent prior to their entry into the study protocol. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences - CompRehab | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University | Wright Medical Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Difference Between Michigan Hand Outcomes Questionnaire Scores | Developed at the University of Michigan Department of Plastic Surgery to evaluate outcomes and function in patients who sustain upper extremity injuries. This will be done one week post-surgery compared to six weeks post-surgery comparing the two groups. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. The overall MHQ score ranged between 0-100. Higher scores indicate better hand performance. | two week post-surgery compared to six weeks post-surgery | |
Secondary | Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) | The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Each question is scored 1-5 with 1 meaning the least amount of severity of pain or difficulty and 5 meaning the maximum amount of pain or difficulty possible. At least 27 of the 30 items must be completed for a score to be calculate. All responses are summed and averaged producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. The overall DASH score ranged between 0-100. A higher score indicated greater disability. | two week post-surgery compared with six weeks post-surgery |
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