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NCT00654615 · ClinicalTrials.gov registry record · NA
Fixation of Unstable Distal Radius Fractures
A NA study, sponsored by Wake Forest University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT00654615: Completed NA study, sponsored by Wake Forest University.
NCT00654615 is a NA study that has completed, run by Wake Forest University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00654615, a NA study, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 ha
Interventions
- DEVICE Intramedullary Radius Fixation (Micronail)
- PROCEDURE Volar Plate Fixation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-05 |
| Est. Completion | 2013-09 |
| Phase | NA |
What the finished NCT00654615 record still lists
NCT00654615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Intramedullary Radius Fixation (Micronail) is the first listed.
NCT00654615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00654615 about?
NCT00654615 is a clinical study titled "Fixation of Unstable Distal Radius Fractures". 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 sur...
What is the current status of trial NCT00654615?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2008-05. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00654615?
The interventions under investigation include: Intramedullary Radius Fixation (Micronail) (DEVICE), Volar Plate Fixation (PROCEDURE).
Who is sponsoring clinical trial NCT00654615?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00654615's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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