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

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001062 on ClinicalTrials.gov