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Timing of Weight Bearing After Hallux Valgus Surgery

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ClinicalTrials.gov Identifier: NCT03340415
Recruitment Status : Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Samuel KK Ling, 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.

Condition or disease Intervention/treatment Phase
Hallux Valgus and Bunion Other: Accelerated Rehabilitation plan Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Surgeon blinded
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Rehab
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
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
early weight bearing after surgery




Primary Outcome Measures :
  1. Radiological changes (HVA, IMA, Tibial sesamoid position) [ Time Frame: 26 weeks post-surgery ]
    Weight bearing feet X-Ray to measure radiological parameters of hallux valgus

  2. Pain VAS [ Time Frame: 26 weeks post-surgery ]
    measurement of the pain using the visual analogue score

  3. Hallux Range of Motion [ Time Frame: 26 weeks post-surgery ]
    ROM at the 1st metatarsal-phalangeal joint

  4. Foot function [ Time Frame: 26 weeks post-surgery ]
    Calculation of foot function using the American Orthopaedic Foot and Ankle Score hallux score (total 0-100)

  5. Foot function [ Time Frame: 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.


Secondary Outcome Measures :
  1. Intermediate Radiological changes (HVA, IMA, Tibial sesamoid position) [ Time Frame: 12 weeks post-surgery ]
    Weight bearing feet X-Ray to measure radiological parameters of hallux valgus

  2. Intermediate Pain [ Time Frame: 12 weeks post-surgery ]
    measurement of the pain using the visual analogue score

  3. Intermediate Hallux Range of Motion [ Time Frame: 12 weeks post-surgery ]
    ROM at the 1st metatarsal-phalangeal joint

  4. Early Hallux Range of Motion [ Time Frame: 6 weeks post-surgery ]
    ROM at the 1st metatarsal-phalangeal joint

  5. Early Pain [ Time Frame: 6 weeks post-surgery ]
    measurement of the pain using the visual analogue score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340415


Locations
Hong Kong
North District Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
North District Hospital
Chinese University of Hong Kong
Investigators
Principal Investigator: Samuel KK Ling, MBChB Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong

Publications of Results:
Responsible Party: Samuel KK Ling, Orthopaedic Surgeon, North District Hospital
ClinicalTrials.gov Identifier: NCT03340415     History of Changes
Other Study ID Numbers: HVrehab
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel KK Ling, North District Hospital:
Hallux Valgus
Bunion
Post-operative
Rehabilitation
Weight Bearing Status

Additional relevant MeSH terms:
Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired