Hand Fractures
Conditions
Keywords
hand, fracture, osteosynthesis, screw, plate, k-wire, phalanx, metacarpal
Brief 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 (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
DEVICEPercutaneous pinning
Similar to arm - closed reduction, two percutaneous pins
DEVICELocked plate
Similar to arm - open reduction, dorsal approach, 3 screws proximal and distal
DEVICEIntramedullary screw
Similar to arm - 1 cm dorsal incision, closed reduction, internal compression screw
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulp-to-palm distance at 6 weeks | at 6 weeks | Global range of motion measured by pulp-to-palm distance at 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | at 3 weeks, 6 weeks, 3months, 6 months and 12 months | Flexion and extension angle in degrees for MCP and PIP joints |
| Bone Healing | 3weeks, 6 weeks, 3months, 6months, 12months | Radiographical bone healing with routine AP and lateral x-rays |
| Cost analysis of each technique at 12months | 12months | Relative cost between each technique for intra and post operative care |
| Complications | 3weeks, 6 weeks, 3months, 6months, 12months | Every clinical and paraclinical complication that may occur |
| Grip strength | 3months, 6months, 12months | Grip strength measured in kg with a validated JAMAR® Hand Dynamometer |
| QuickDASH PROM score | 3months, 6months, 12months | Functional recovery evaluated with the QuickDASH PROM score |
| Patient satisfaction | 3months, 6months, 12months | Patient satisfaction evaluated with visual analogue scale (VAS) |
Countries
France
Contacts
CONTACTPierre-Emmanuel Chammas, MD, MSc
PRINCIPAL_INVESTIGATORPierre-Emmanuel Chammas, MD, MSc
University Hospital, Montpellier
Outcome results
None listed