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NCT01589692 · ClinicalTrials.gov registry record · NA
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 304
- Enrollment target
NCT01589692 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 304 participants.
The verdict
NCT01589692, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 304 participants
- Enrollment target
Study Summary
In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches. The specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.
Interventions
- PROCEDURE Open Reduction and Internal Fixation
- PROCEDURE External Fixation
- PROCEDURE Percutaneous Pinning
- PROCEDURE Closed Reduction and casting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2012-04-10 |
| Est. Completion | 2019-01-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01589692
The ClinicalTrials.gov registry entry for NCT01589692 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Open Reduction and Internal Fixation is the first listed.
NCT01589692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01589692 about?
NCT01589692 is a clinical study titled "A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures". In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical techni...
What is the current status of trial NCT01589692?
This trial is currently completed. It is a NA study. The enrollment target is 304 participants. The study started on 2012-04-10. Estimated completion is 2019-01-08.
What interventions are being tested in trial NCT01589692?
The interventions under investigation include: Open Reduction and Internal Fixation (PROCEDURE), External Fixation (PROCEDURE), Percutaneous Pinning (PROCEDURE), Closed Reduction and casting (PROCEDURE).
Who is sponsoring clinical trial NCT01589692?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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