Buddy Tape vs. Splint for Metacarpal Shaft Fracture Recovery (SYNATIP)

Functional Treatment of Non-thumb Metacarpal Shaft Fractures. Randomized Study Evaluating Buddy Taping Versus Splint on Functional Recovery of the Hand

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.

Study Overview

• Status: Recruiting
• Conditions: Non-thumb Metacarpal Shaft Fracture
• Intervention / Treatment: Device: buddy tape; Device: splint

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adnan FOUFA, MD; Phone Number: 33 1 61 69 55 10; Email: adnan.foufa@chsf.fr
• Study Contact Backup: Name: Caroline TOURTE

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Recruiting
    • Centre Hospitalier Sud Francilien
    • Contact: Clément BOUFFLERD, MD; Phone Number: 33 1 61 69 81 44; Email: clement.boufflerd@chsf.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: splint	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
Experimental: buddy	Device: buddy tape; Buddy-taping a finger dynamically splints one finger to an adjacent, uninjured finger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Dash	Auto questionnaire evaluating the disabilities of the arm, shoulder and hand	day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clamp force	Clamp force deficit measured by a hydraulic hand dynamometer	day 0,15,30,60 and 90
Grip force	Grip force deficit measured by a hydraulic hand dynamometer	day 0,15,30,60 and 90
TPM	Total passive motion measured with a digital goniometer	day 0,15,30,60 and 90
TAM	Total active motion measured with a digital goniometer	day 0,15,30,60 and 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Metacarpal shaft fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Splints
• Other Study ID Numbers: 2024-A02344-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No