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

Centre Hospitalier Sud Francilien

Status: Not yet enrolling

Conditions: Non-thumb Metacarpal Shaft Fracture

Treatments: Device: splint; Device: buddy tape

Study type: Interventional

Funder types: Other

Identifiers

NCT06734364

2024-A02344-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

buddy

Experimental group

Treatment:

Device: buddy tape

splint

Active Comparator group

Treatment:

Device: splint