Non-thumb Metacarpal Shaft FractureSYNATIPNCT06734364
Buddy Tape vs. Splint for Metacarpal Shaft Fracture Recovery
A study testing buddy tape and splint in people with Non-thumb Metacarpal Shaft Fracture, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-thumb Metacarpal Shaft Fracture
- What is being tested?
- buddy tape and splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2025to 5 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caroline TOURTE contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Clément BOUFFLERD, MD, 33 1 61 69 81 44, clement.boufflerd@chsf.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-thumb Metacarpal Shaft Fracture
- Being tested
- buddy tape, splint
- Keywords
- Metacarpal shaft fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buddy tapeDevice
Buddy-taping a finger dynamically splints one finger to an adjacent, uninjured finger.
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
| Study group | Role | What they receive |
|---|---|---|
| buddy | Experimental | Not described Receives: Device: buddy tape |
| splint | Active comparator | Not described Receives: Device: splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Dash
Auto questionnaire evaluating the disabilities of the arm, shoulder and hand
Measured: day 60
Secondary outcomes (4)
clamp force
Clamp force deficit measured by a hydraulic hand dynamometer
Measured: day 0,15,30,60 and 90
Grip force
Grip force deficit measured by a hydraulic hand dynamometer
Measured: day 0,15,30,60 and 90
TPM
Total passive motion measured with a digital goniometer
Measured: day 0,15,30,60 and 90
TAM
Total active motion measured with a digital goniometer
Measured: day 0,15,30,60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start5 Nov 2025
- Primary completion5 Feb 2028 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-thumb Metacarpal Shaft FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734364
- Sponsor's protocol ID
- 2024-A02344-43
- Acronym
- SYNATIP
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Treatment of Non-thumb Metacarpal Shaft Fractures. Randomized Study Evaluating Buddy Taping Versus Splint on Functional Recovery of the Hand
- ClinicalTrials.gov ID
- NCT06734364
- Acronym / sponsor ID
- SYNATIP / 2024-A02344-43
- Conditions
- Non-thumb Metacarpal Shaft Fracture
- Keywords
- Metacarpal shaft fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 5 Feb 2028 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buddy | Experimental | Device: buddy tape |
| splint | Active comparator | Device: splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buddy tapeBuddy-taping a finger dynamically splints one finger to an adjacent, uninjured finger. | Device | buddy |
| splintShort 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 | Device | splint |
Primary outcome
Quick Dash
Time frame: day 60
Auto questionnaire evaluating the disabilities of the arm, shoulder and hand
4 secondary outcomes
clamp force
Time frame: day 0,15,30,60 and 90
Grip force
Time frame: day 0,15,30,60 and 90
TPM
Time frame: day 0,15,30,60 and 90
TAM
Time frame: day 0,15,30,60 and 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline TOURTE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buddy tape and splint in people with Non-thumb Metacarpal Shaft Fracture, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan FOUFA, MD (33 1 61 69 55 10, adnan.foufa@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Dash (time frame: day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.