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Timing of Weight Bearing After Hallux Valgus Surgery

Primary Purpose

Hallux Valgus and Bunion

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Accelerated Rehabilitation plan
Sponsored by
North District Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus and Bunion focused on measuring Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • North District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Rehab

Accelerated Rehab

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 7, 2017
Last Updated
March 1, 2021
Sponsor
North District Hospital
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03340415
Brief Title
Timing of Weight Bearing After Hallux Valgus Surgery
Official Title
Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North District Hospital
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus and Bunion
Keywords
Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Surgeon blinded
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Rehab
Arm Type
No Intervention
Arm Description
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
Arm Title
Accelerated Rehab
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Accelerated Rehabilitation plan
Intervention Description
early weight bearing after surgery
Primary Outcome Measure Information:
Title
Hallux Valgus Angle as a Measure of the Radiological Changes
Description
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.
Time Frame
0, 12, 26 weeks post-surgery
Title
Inter-metatarsal Angle as a Measure of the Radiological Changes
Description
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.
Time Frame
0, 12, 26 weeks post-surgery
Title
Radiological Changes (Tibial Sesamoid Position)
Description
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.
Time Frame
0, 12, 26 weeks post-surgery
Secondary Outcome Measure Information:
Title
Foot Function (FAOS Symptoms)
Description
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.
Time Frame
0, 12, 26 week post-surgery
Title
Foot Function (FAOS Pain)
Description
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.
Time Frame
0, 12, 26 week post-surgery
Title
Foot Function (FAOS ADL)
Description
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.
Time Frame
0, 12, 26 week post-surgery
Title
Foot Function (FAOS Sport)
Description
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.
Time Frame
0, 12, 26 week post-surgery
Title
Foot Function (FAOS QoL)
Description
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.
Time Frame
0, 12, 26 week post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel KK Ling, MBChB
Organizational Affiliation
Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
North District Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26752780
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.
Results Reference
result
PubMed Identifier
28580264
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.
Results Reference
result
PubMed Identifier
16325100
Citation
Lui TH, Ng S, Chan KB. Endoscopic distal soft tissue procedure in hallux valgus surgery. Arthroscopy. 2005 Nov;21(11):1403. doi: 10.1016/j.arthro.2005.08.015.
Results Reference
result
PubMed Identifier
20678710
Citation
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.
Results Reference
result

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Timing of Weight Bearing After Hallux Valgus Surgery

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