NCT03340415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

November 7, 2017

Results QC Date

September 8, 2020

Last Update Submit

March 1, 2021

Conditions

Hallux Valgus and Bunion

Keywords

Hallux ValgusBunionPost-operativeRehabilitationWeight Bearing Status

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Foot Function (FAOS Symptoms)

    0, 12, 26 week post-surgery

  • Foot Function (FAOS Pain)

    0, 12, 26 week post-surgery

  • Foot Function (FAOS ADL)

    0, 12, 26 week post-surgery

  • Foot Function (FAOS Sport)

    0, 12, 26 week post-surgery

  • Foot Function (FAOS QoL)

    0, 12, 26 week post-surgery

Study Arms (2)

Control Rehab

NO INTERVENTION

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 Rehab

EXPERIMENTAL

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

Interventions

Accelerated Rehabilitation planOTHER

early weight bearing after surgery

Accelerated Rehab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing the EDSTP recruited

You may not qualify if:

  • Cases requiring additional procedures (eg 2nd toe correction)
  • Mental incapacitation
  • Physical disability hindering rehabilitation (eg CVA, neurological disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North District Hospital

Hong Kong, Hong Kong

Location

Related Publications (4)

  • 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.

    PMID: 26752780RESULT

  • 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.

    PMID: 28580264RESULT

  • 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.

    PMID: 16325100RESULT

  • 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.

    PMID: 20678710RESULT

MeSH Terms

Conditions

Hallux ValgusBunion

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesFoot Deformities, Acquired

Results Point of Contact

Title
Dr Samuel Ling
Organization
CUHK
samuel-kk-ling@alumni.cuhk.net
35052010

Study Officials

  • Samuel KK Ling, MBChB

    Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Surgeon blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 13, 2017

Study Start

July 13, 2018

Primary Completion

June 30, 2019

Study Completion

April 30, 2020

Last Updated

March 24, 2021

Results First Posted

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)