Timing of Weight Bearing After Hallux Valgus Surgery

Not Applicable

Completed

Conditions: Hallux Valgus and Bunion

Registration Number: NCT03340415

Lead Sponsor: North District Hospital

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hallux Valgus Angle as a Measure of the Radiological Changes	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	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)	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 Outcome Measures

Name	Time	Method
Foot Function (FAOS ADL)	0, 12, 26 week post-surgery	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.
Foot Function (FAOS QoL)	0, 12, 26 week post-surgery	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.
Foot Function (FAOS Symptoms)	0, 12, 26 week post-surgery	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.
Foot Function (FAOS Pain)	0, 12, 26 week post-surgery	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.
Foot Function (FAOS Sport)	0, 12, 26 week post-surgery	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.