Hand FracturesFinXgerNCT07186829
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
A study testing Percutaneous pinning, Locked plate and Intramedullary screw in people with Hand Fractures, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The goal of this randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Fractures
- What is being tested?
- Percutaneous pinning, Locked plate and Intramedullary screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2026to 15 Dec 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
- Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication
Who cannot join
- Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital of Montpellier
Montpellier, Occitanie, 34090
Pierre-Emmanuel Chammas, MD, MSc, +330467338537, pe-chammas@chu-montpellier.fr
About this study
Official title: Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers: Centromedullary Screw Osteosynthesis Versus Pinning Versus Locked Plate.
The goal of this randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals (excluding the thumb) in adult patients. The main questions it aims to answer are:
The primary outcome is to define which technique results in better functional outcomes, as measured by pulp-to-palm distance at 6 weeks?
Read more
The main secondary outcome is to define which technique has lower complication rates and is more cost-effective over 12 months?
Participants will be randomly assigned to one of the three surgical techniques (intramedullary screw fixation, locked plating, or percutaneous pinning). Follow-up visits at weeks: 3, 6 and months: 3,6 and final follow-up at 12 months will assess hand function, range of motion, grip strength, radiographic healing, complications, satisfaction, and costs.
- Conditions
- Hand Fractures
- Being tested
- Percutaneous pinning, Locked plate, Intramedullary screw
- Keywords
- hand, fracture, osteosynthesis, screw, plate, k-wire, phalanx, metacarpal
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous pinningDevice
Also called K-wire, Kirchner wire
Similar to arm - closed reduction, two percutaneous pins
Locked plateDevice
Also called Locking plate
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Intramedullary screwDevice
Also called Intramedullary compression screw, Herbert screw
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous pinning | Active comparator | closed reduction, two percutaneous pins Receives: Device: Percutaneous pinning |
| Locked plate | Active comparator | open reduction, dorsal approach, 3 screws proximal and distal Receives: Device: Locked plate |
| Intramedullary screw | Active comparator | 1 cm dorsal incision, closed reduction, internal compression screw Receives: Device: Intramedullary screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp-to-palm distance at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
Measured: at 6 weeks
Secondary outcomes (7)
Range of motion
Flexion and extension angle in degrees for MCP and PIP joints
Measured: at 3 weeks, 6 weeks, 3months, 6 months and 12 months
Bone Healing
Radiographical bone healing with routine AP and lateral x-rays
Measured: 3weeks, 6 weeks, 3months, 6months, 12months
Cost analysis of each technique at 12months
Relative cost between each technique for intra and post operative care
Measured: 12months
Complications
Every clinical and paraclinical complication that may occur
Measured: 3weeks, 6 weeks, 3months, 6months, 12months
Grip strength
Grip strength measured in kg with a validated JAMAR® Hand Dynamometer
Measured: 3months, 6months, 12months
QuickDASH PROM score
Functional recovery evaluated with the QuickDASH PROM score
Measured: 3months, 6months, 12months
Patient satisfaction
Patient satisfaction evaluated with visual analogue scale (VAS)
Measured: 3months, 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Dec 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Emmanuel Chammas, MD, MSc, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186829
- Sponsor's protocol ID
- RECHMPL24_0382
- Acronym
- FinXger
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 26 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers: Centromedullary Screw Osteosynthesis Versus Pinning Versus Locked Plate.
- ClinicalTrials.gov ID
- NCT07186829
- Acronym / sponsor ID
- FinXger / RECHMPL24_0382
- Conditions
- Hand Fractures
- Keywords
- hand, fracture, osteosynthesis, screw, plate, k-wire, phalanx, metacarpal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 22 Sep 2025 (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 randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals (excluding the thumb) in adult patients. The main questions it aims to answer are:
The primary outcome is to define which technique results in better functional outcomes, as measured by pulp-to-palm distance at 6 weeks?
The main secondary outcome is to define which technique has lower complication rates and is more cost-effective over 12 months?
Participants will be randomly assigned to one of the three surgical techniques (intramedullary screw fixation, locked plating, or percutaneous pinning). Follow-up visits at weeks: 3, 6 and months: 3,6 and final follow-up at 12 months will assess hand function, range of motion, grip strength, radiographic healing, complications, satisfaction, and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous pinning | Active comparator | Device: Percutaneous pinningclosed reduction, two percutaneous pins |
| Locked plate | Active comparator | Device: Locked plateopen reduction, dorsal approach, 3 screws proximal and distal |
| Intramedullary screw | Active comparator | Device: Intramedullary screw1 cm dorsal incision, closed reduction, internal compression screw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication
Key exclusion criteria (1 listed)
- Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent
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 |
|---|---|---|
| Percutaneous pinningAlso: K-wire, Kirchner wireSimilar to arm - closed reduction, two percutaneous pins | Device | Percutaneous pinning |
| Locked plateAlso: Locking plateSimilar to arm - open reduction, dorsal approach, 3 screws proximal and distal | Device | Locked plate |
| Intramedullary screwAlso: Intramedullary compression screw, Herbert screwSimilar to arm - 1 cm dorsal incision, closed reduction, internal compression screw | Device | Intramedullary screw |
Primary outcome
Pulp-to-palm distance at 6 weeks
Time frame: at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
7 secondary outcomes
Range of motion
Time frame: at 3 weeks, 6 weeks, 3months, 6 months and 12 months
Bone Healing
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Cost analysis of each technique at 12months
Time frame: 12months
Complications
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Grip strength
Time frame: 3months, 6months, 12months
QuickDASH PROM score
Time frame: 3months, 6months, 12months
Patient satisfaction
Time frame: 3months, 6months, 12months
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 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hand Fractures
Recruiting
Buddy Tape vs. Splint for Metacarpal Shaft Fracture Recovery
Non-thumb Metacarpal Shaft Fracture
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Not yet recruiting
Lipofilling in Operative Hand Fracture Treatment
Adhesions, Hand Fractures
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
RecruitingObservational study
Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
Hand Injuries, Forearm Fractures
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.
Pierre-Emmanuel Chammas, MD, MSc principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous pinning, Locked plate and Intramedullary screw in people with Hand Fractures, run by University Hospital, Montpellier 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 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 Pierre-Emmanuel Chammas, MD, MSc (+33467338537, pe-chammas@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp-to-palm distance at 6 weeks (time frame: at 6 weeks). 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 26 Oct 2026.