Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutanous pinning, Locked plate, Intramedullary screw.
- Who it may be relevant to
- Registry conditions: Hand Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device Percutanous pinning
Similar to arm - closed reduction, two percutaneous pins - Device Locked plate
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal - Device Intramedullary screw
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Primary outcome measures
- Pulp-to-palm distance at 6 weeks [Time frame: at 6 weeks]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication
Exclusion criteria
- Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- University Hospital of Montpellier — Montpellier
Identifiers
NCT: NCT07186829 · RECHMPL24_0382