Fixation of Unstable Distal Radius Fractures
Completed · Not applicable
Conditions studied: Distal Radius Fractures
In brief
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.
Key facts
- Study ID
- NCT00654615
- Run by
- Wake Forest University
- People needed
- 60
- Starts
- 2008-05-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2018-09-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Wake Forest University Health Sciences - CompRehab — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.