Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Hallux Valgus Angle as a Measure of the Radiological Changes
Study Overview
Brief Summary
Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis: Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus Correction.
Detailed Description
Introduction:
- Rehabilitation plans after hallux valgus/bunion surgery is varied
- From a patient's perspective, full weight bearing is paramount for quality of life and return to work/study
- No high-level study showing the optimal time to resume full weight bearing available
Hypothesis:
Early weight bearing (at 2 weeks post-op) does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus correction
Trial Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Surgeon blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients undergoing the EDSTP recruited
Exclusion Criteria
- •Cases requiring additional procedures (eg 2nd toe correction)
- •Mental incapacitation
- •Physical disability hindering rehabilitation (eg CVA, neurological disorder)
Arms & Interventions
Control Rehab
Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
Accelerated Rehab
Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
Intervention: Accelerated Rehabilitation plan (Other)
Outcomes
Primary Outcomes
Hallux Valgus Angle as a Measure of the Radiological Changes
Time Frame: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is the angle between the 1st metatarsal and the proximal phalanx.
Inter-metatarsal Angle as a Measure of the Radiological Changes
Time Frame: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is measure using the bisecting line between the 1st metatarsal and the 2nd metatarsal.
Radiological Changes (Tibial Sesamoid Position)
Time Frame: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. 4 represents the most neutral position. bigger difference from 4 means more severe condition. This a score from 0-7.
Secondary Outcomes
- Foot Function (FAOS ADL)(0, 12, 26 week post-surgery)
- Foot Function (FAOS QoL)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Symptoms)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Pain)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Sport)(0, 12, 26 week post-surgery)
Investigators
Samuel KK Ling
Orthopaedic Surgeon
Chinese University of Hong Kong