Ankle Fractures, Unstabel Ankle Fractures
Conditions
Keywords
Ankle fracture, Immediate protected weight bearing, Rehabilitation, Walker boot, Randomized controlled trial
Brief summary
This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Participants are randomized to immediate protected weight bearing from the first postoperative day using a Walker boot and crutches or conventional non-weight bearing for six weeks. Functional outcome (OMAS), pain (VAS), ankle range of motion, quality of life (SF-12), and postoperative complications are assessed over 12 months.
Interventions
OTHERImmediate protected weight bearing
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches
OTHERRehabilitation
Standardised rehabilitation after surgery
Sponsors
Consorci Sanitari Integral
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Unstable ankle fracture requiring ORIF. * Written informed consent.
Exclusion criteria
* Psychiatric disorder. * Pre-existing mobility limitation. * Cognitive impairment. * BMI \>30 kg/m². * Poorly controlled type 2 diabetes. * Soft tissue injury requiring external fixation. * Gustilo II/III open fractures. * Unstable fixation. * Refusal/inability to consent or allow anonymized data use. * Any condition compromising safety or validity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Olerud-Molander Ankle Score (OMAS). | 6 weeks, 12 weeks, 6 months and 12 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogic Scale (VAS) for pain | 6 weeks, 12 weeks, 6 months and 12 months. |
| SF-12 quality of life | 6 weeks, 12 weeks, 6 months and 12 months. |
Countries
Spain
Outcome results
None listed