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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutanous pinning | Active Comparator | closed reduction, two percutaneous pins |
|
| Locked plate | Active Comparator | open reduction, dorsal approach, 3 screws proximal and distal |
|
| Intramedullary screw | Active Comparator | 1 cm dorsal incision, closed reduction, internal compression screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutanous pinning | Device | Similar to arm - closed reduction, two percutaneous pins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulp-to-palm distance at 6 weeks | Global range of motion measured by pulp-to-palm distance at 6 weeks | at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | Flexion and extension angle in degrees for MCP and PIP joints | at 3 weeks, 6 weeks, 3months, 6 months and 12 months |
| Bone Healing | Radiographical bone healing with routine AP and lateral x-rays |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Emmanuel Chammas, MD, MSc | Contact | +33467338537 | pe-chammas@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre-Emmanuel Chammas, MD, MSc | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier | Montpellier | Occitanie | 34090 | France |
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| Locked plate | Device | Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal |
|
|
| Intramedullary screw | Device | Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw |
|
|
| 3weeks, 6 weeks, 3months, 6months, 12months |
| Cost analysis of each technique at 12months | Relative cost between each technique for intra and post operative care | 12months |
| Complications | Every clinical and paraclinical complication that may occur | 3weeks, 6 weeks, 3months, 6months, 12months |
| Grip strength | Grip strength measured in kg with a validated JAMARĀ® Hand Dynamometer | 3months, 6months, 12months |
| QuickDASH PROM score | Functionnal recovery evaluated with the QuickDASH PROM score | 3months, 6months, 12months |
| Patient satisfaction | Patient satisfaction evaluated with visual analogue scale (VAS) | 3months, 6months, 12months |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
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