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NCT04001062 · ClinicalTrials.gov registry record · NA
Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT04001062: Clinical Trial NA study, sponsored by University of Missouri-Columbia.
NCT04001062 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04001062, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
There is a lack of strong evidence guiding the treatment of non-thumb isolated closed metacarpal shaft fractures towards operative fixation versus conservative management. Surgical approach is largely decided by surgeon preference/skill, qualities of fracture, and extent of injury. Previous studies have shown that many metacarpal fractures can be treated non-operatively, with outcomes being as good as or better than those treated with surgery. Surgery using plates can often cause stiffness, contractures, and in rare causes nonunion infection or tendon rupture. This study will seek to build upon previous evidence to help guide future surgeons as they decide how to approach a closed non-thumb metacarpal fractures. Patients will be identified in clinic after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the non-operative or surgical group. This decision will be done through randomization.The investigators anticipate that 100 subjects will be enrolled. Patient reported outcomes, including the PROMIS forms, Disabilities of the Arm, Shoulder and Hand (DASH) surveys and Visual Analog Scale (VAS) will be recorded. Range of motion will be assessed at all time points along with grip strength. X-rays will be evaluated for metacarpal shortening, rotation or non-union. In addition, time for clinical and radiologic union will be documented.
Primary Outcome
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 being "no pain" and 10 being "worst pain."
Interventions
- PROCEDURE Surgical Fixation
- OTHER Non-Operative Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2022-04-15 |
| Phase | NA |
Why NCT04001062 stopped before completion
NCT04001062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgical Fixation is the first listed.
NCT04001062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04001062 about?
NCT04001062 is a clinical study titled "Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures". There is a lack of strong evidence guiding the treatment of non-thumb isolated closed metacarpal shaft fractures towards operative fixation versus conservative management. Surgical approach is largely decided by surgeon preference/skill, qualities of fracture, and extent of injury. Previous studies ...
What is the current status of trial NCT04001062?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2019-06-12. Estimated completion is 2022-04-15.
What interventions are being tested in trial NCT04001062?
The interventions under investigation include: Surgical Fixation (PROCEDURE), Non-Operative Management (OTHER).
Who is sponsoring clinical trial NCT04001062?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04001062's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 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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