Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures
NCT04001062 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2023-06-29
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.
Conditions
- Metacarpal Fracture
Interventions
- PROCEDURE
-
Surgical Fixation
For both scissoring and non-scissoring injuries surgical fixation by either pinning, dorsal plate, or lag screws will be considered. This will be determined by surgeon expertise at the time of surgical fixation. Postoperative, a volar short arm splint and immediate AROM at full range with buddy taping to adjacent digit will be indicated. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
- OTHER
-
Non-Operative Management
1. For non-scissoring injuries: Placement of short-arm cast; immediate AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of \<2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union. 2. For scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of \<2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union
Sponsors & Collaborators
-
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Jay Bridgeman, MD · University of Missouri-Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-12
- Primary Completion
- 2022-04-15
- Completion
- 2022-04-15
Countries
- United States
Study Locations
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