Timing of Weight Bearing After Hallux Valgus Surgery

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: Parallel group Random allocation Operating Surgeon blind to randomisation Study Setting: General Regional Hospital Single Centre

Official Title
-----------------
Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery

Conditions
-----------------
Hallux Valgus and Bunion

Intervention / Treatment
-----------------
* Other: Accelerated Rehabilitation plan


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Rehab<br>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 | |
| Experimental: Accelerated Rehab<br>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 | Other: Accelerated Rehabilitation plan<br>* early weight bearing after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hallux Valgus Angle as a Measure of the Radiological Changes | 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. | 0, 12, 26 weeks post-surgery | 
| Inter-metatarsal Angle as a Measure of the Radiological Changes | 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. | 0, 12, 26 weeks post-surgery | 
| Radiological Changes (Tibial Sesamoid Position) | 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. | 0, 12, 26 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Function (FAOS Symptoms) | Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 0, 12, 26 week post-surgery | 
| Foot Function (FAOS Pain) | Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 0, 12, 26 week post-surgery | 
| Foot Function (FAOS ADL) | Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 0, 12, 26 week post-surgery | 
| Foot Function (FAOS Sport) | Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 0, 12, 26 week post-surgery | 
| Foot Function (FAOS QoL) | Calculation of foot function using the self-reported Foot and Ankle Outcome Score (FAOS): FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport and Recreation), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 0, 12, 26 week post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status