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Buddy Tape vs. Splint for Metacarpal Shaft Fracture Recovery

NCT ID: NCT06734364

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2027-02-05

Brief Summary

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The goal of this clinical trial is to see if buddy tape can treat shaft fracture of hand long fingers as well as splint.

The main question it aims to answer is: Two months after the fracture, are the hand activities as good with buddy taping as with splint? Researchers will compare buddy tape group to splint group to see if the strength of the arm is not lower with buddy tape.

Participants will attend 4 visits after receiving either buddy tape or splint, to control their hand strength and the correct healing of their franture.

Detailed Description

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Patients will be identified in the emergency ward 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 buddy taping or the short arm splint group. This decision will be made through randomization, and the physician will not select which group the patient is in.

As in routine practice, the patients are seen again on D15 ± 3 days, D30 ± 5 days and D60 ± 5 days in an orthopedic consultation with X-ray to control the hand face, strict profile and 3/4. Both devices are removed at the check-up consultation on day 30 ± 5 days.

The patients will then attend the end of trial visit at Day 90 ± 5 days in an orthopedic consultation with X-ray.

No specific act is added by this research.

Conditions

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Non-thumb Metacarpal Shaft Fracture

Keywords

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Metacarpal shaft fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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buddy

Group Type EXPERIMENTAL

buddy tape

Intervention Type DEVICE

Buddy-taping a finger dynamically splints one finger to an adjacent, uninjured finger.

splint

Group Type ACTIVE_COMPARATOR

splint

Intervention Type DEVICE

Short arm splint immobilize and maintain stability of the injured finger, the hand is immobilized in the intrinsic plus position with syndactyly of the injured finger and adjacent finger

Interventions

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buddy tape

Buddy-taping a finger dynamically splints one finger to an adjacent, uninjured finger.

Intervention Type DEVICE

splint

Short arm splint immobilize and maintain stability of the injured finger, the hand is immobilized in the intrinsic plus position with syndactyly of the injured finger and adjacent finger

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult patient
2. Fingers 2 to 5 metacarpal shaft fracture, little or no displacement
3. Tilt less than or equal to thirty degrees
4. No rotation disorder
5. Patient who has given consent to participate in the study and has signed an informed consent

Exclusion Criteria

1. Surgical treatment indicated
2. Patient pregnant or likely to be pregnant
3. Patient who does not speak or understand French
4. Subject under guardianship or curatorship
5. Subject not beneficiary of a social security system.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Adnan FOUFA, MD

Role: CONTACT

Phone: 33 1 61 69 55 10

Email: [email protected]

Caroline TOURTE

Role: CONTACT

Facility Contacts

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Clément BOUFFLERD, MD

Role: primary

Other Identifiers

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2024-A02344-43

Identifier Type: -

Identifier Source: org_study_id