Timing of Weight Bearing After Hallux Valgus Surgery

Hallux Valgus and Bunion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340415
• Other study ID #: HVrehab
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: North District Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Hallux Valgus and Bunion

Intervention

Other:
• Accelerated Rehabilitation plan
early weight bearing after surgery

Locations

Country	Name	City	State
Hong Kong	North District Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
North District Hospital	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

Lui TH, Chan KB, Chan LK. Endoscopic distal soft-tissue release in the treatment of hallux valgus: a cadaveric study. Arthroscopy. 2010 Aug;26(8):1111-6. doi: 10.1016/j.arthro.2009.12.027. — View Citation

Lui TH, Ling SK, Yuen SC. Endoscopic-assisted Correction of Hallux Valgus Deformity. Sports Med Arthrosc Rev. 2016 Mar;24(1):e8-13. doi: 10.1097/JSA.0000000000000078. — View Citation

Lui TH, Ng S, Chan KB. Endoscopic distal soft tissue procedure in hallux valgus surgery. Arthroscopy. 2005 Nov;21(11):1403. — View Citation

Lui TH. Correction of Recurred Hallux Valgus Deformity by Endoscopic Distal Soft Tissue Procedure. Arthrosc Tech. 2017 Apr 10;6(2):e435-e440. doi: 10.1016/j.eats.2016.10.022. eCollection 2017 Apr. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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