Timing of Weight Bearing After Hallux Valgus Surgery

NCT ID: NCT03340415

Last Updated: 2021-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2020-04-30

Brief Summary

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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

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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

Conditions

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Hallux Valgus and Bunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Surgeon blinded

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Accelerated Rehabilitation plan

Intervention Type OTHER

early weight bearing after surgery

Interventions

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Accelerated Rehabilitation plan

early weight bearing after surgery

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

North District Hospital

OTHER

Sponsor Role lead

Responsible Party

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Samuel KK Ling

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel KK Ling, MBChB

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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North District Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type RESULT
PMID: 26752780 (View on PubMed)

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.

Reference Type RESULT
PMID: 28580264 (View on PubMed)

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.

Reference Type RESULT
PMID: 16325100 (View on PubMed)

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.

Reference Type RESULT
PMID: 20678710 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HVrehab

Identifier Type: -

Identifier Source: org_study_id

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