NCT06023979

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

Detailed description

This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Conditions

• Post Operative Treatment After Unstable Malleolar Fractures

Interventions

Type	Name	Description
OTHER	Full weight bearing	Full weight bearing monitored with a bio-feedback insole
OTHER	Partial weight bearing	Partial weight bearing monitored with a bio-feedback insole

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-10-31
• Completion: 2026-10-31
• First posted: 2023-09-05
• Last updated: 2023-09-05

Locations

1 site across 1 country: Switzerland