Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
NCT ID: NCT07186829
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
111 participants
INTERVENTIONAL
2025-11-30
2027-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Percutanous pinning
closed reduction, two percutaneous pins
Percutanous pinning
Similar to arm - closed reduction, two percutaneous pins
Locked plate
open reduction, dorsal approach, 3 screws proximal and distal
Locked plate
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Intramedullary screw
1 cm dorsal incision, closed reduction, internal compression screw
Intramedullary screw
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Interventions
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Percutanous pinning
Similar to arm - closed reduction, two percutaneous pins
Locked plate
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Intramedullary screw
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Pierre-Emmanuel Chammas, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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University Hospital of Montpellier
Montpellier, Occitanie, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL24_0382
Identifier Type: -
Identifier Source: org_study_id
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