NCT06734364

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Nov 2025Feb 2027

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2027

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

December 11, 2024

Last Update Submit

December 17, 2025

Conditions

Keywords

Metacarpal shaft fracture

Outcome Measures

Primary Outcomes (1)

  • Quick Dash

    Auto questionnaire evaluating the disabilities of the arm, shoulder and hand

    day 60

Secondary Outcomes (4)

  • clamp force

    day 0,15,30,60 and 90

  • Grip force

    day 0,15,30,60 and 90

  • TPM

    day 0,15,30,60 and 90

  • TAM

    day 0,15,30,60 and 90

Study Arms (2)

buddy

EXPERIMENTAL
Device: buddy tape

splint

ACTIVE COMPARATOR
Device: splint

Interventions

splintDEVICE

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

splint

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

buddy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Surgical treatment indicated
  • Patient pregnant or likely to be pregnant
  • Patient who does not speak or understand French
  • Subject under guardianship or curatorship
  • Subject not beneficiary of a social security system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

RECRUITING

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Central Study Contacts

Caroline TOURTE

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

November 5, 2025

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

February 5, 2027

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations