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NCT Number: NCT03340415

Timing of Weight Bearing After Hallux Valgus Surgery

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.

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Key information

Conditions

Hallux Valgus and Bunion Bunion Foot Deformities Foot Deformities, Acquired Hallux Valgus Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North District Hospital

Hong Kong

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Accelerated Rehabilitation plan

Other

early weight bearing after surgery

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Foot Function (FAOS Symptoms)

    Time frame: 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.

  2. Foot Function (FAOS Pain)

    Time frame: 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.

  3. Foot Function (FAOS ADL)

    Time frame: 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.

  4. Foot Function (FAOS Sport)

    Time frame: 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.

  5. Foot Function (FAOS QoL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

North District Hospital

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 13, 2017
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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