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

Not Applicable

Not yet recruiting

• Conditions: Post Operative Treatment After Unstable Malleolar Fractures

• Registration Number: NCT06023979
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief 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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study Start: 2023-09-01
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-05
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients with surgically stabilized unstable ankle fractures
• signed informed consent
• closed tibial and fibular epiphysis
• age 18 or older

Exclusion Criteria

• dementia and other known cognitive impairment or incapacity of judgement
• polytrauma
• bilateral injury of the lower extremities
• additional injury of the ipsilateral lower extremity which prevents full weight bearing
• associated injury of one or both upper extremities
• open fractures grade II° and III°
• chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
• open epiphysis
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Manchester Oxford Foot and Ankle Questionnaire	1 year	Patient reported Outcome measure

Secondary Outcome Measures

Name	Time	Method
Secondary dislocation of fracture	6 weeks
Range of Motion	1 year
other PROMs (patient reported outcome measures)	1 year

Trial Locations

Locations (1)

Canton Hospital St. Gallen; 🇨🇭 Saint Gallen, Switzerland