Clinical trial NCT03340415: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus and Bunion
Keywords: Hallux Valgus
Bunion
Post-operative
Rehabilitation
Weight Bearing Status
Lead sponsor: North District Hospital
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2017-11-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Hallux Valgus Angle as a Measure of the Radiological Changes
timeFrame: 0, 12, 26 weeks post-surgery
measure: Inter-metatarsal Angle as a Measure of the Radiological Changes
timeFrame: 0, 12, 26 weeks post-surgery
measure: Radiological Changes (Tibial Sesamoid Position)
timeFrame: 0, 12, 26 weeks post-surgery
Secondary outcomes:
measure: Foot Function (FAOS Symptoms)
timeFrame: 0, 12, 26 week post-surgery
measure: Foot Function (FAOS Pain)
timeFrame: 0, 12, 26 week post-surgery
measure: Foot Function (FAOS ADL)
timeFrame: 0, 12, 26 week post-surgery
measure: Foot Function (FAOS Sport)
timeFrame: 0, 12, 26 week post-surgery
measure: Foot Function (FAOS QoL)
timeFrame: 0, 12, 26 week post-surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong
name: Samuel KK Ling, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.