University Hospital of Montpellier
Montpellier, Occitanie, 34090, France
NCT Number: NCT07186829
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Montpellier, Occitanie, 34090, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Similar to arm - closed reduction, two percutaneous pins
Other names: K-wire, Kirchner wire
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
Other names: Locking plate
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Other names: Intramedullary compression screw, Herbert screw
Time frame: at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
Time frame: at 3 weeks, 6 weeks, 3months, 6 months and 12 months
Flexion and extension angle in degrees for MCP and PIP joints
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Radiographical bone healing with routine AP and lateral x-rays
Time frame: 12months
Relative cost between each technique for intra and post operative care
Time frame: 3weeks, 6 weeks, 3months, 6months, 12months
Every clinical and paraclinical complication that may occur
Time frame: 3months, 6months, 12months
Grip strength measured in kg with a validated JAMAR® Hand Dynamometer
Time frame: 3months, 6months, 12months
Functionnal recovery evaluated with the QuickDASH PROM score
Time frame: 3months, 6months, 12months
Patient satisfaction evaluated with visual analogue scale (VAS)
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
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.
Acronym: FinXger
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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