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NCT03340415

Timing of Weight Bearing After Hallux Valgus Surgery

Completed NA Results posted Last updated 24 March 2021
What this trial tests

NA trial testing Accelerated Rehabilitation plan in Hallux Valgus and Bunion in 53 participants. Completed in 30 April 2020.

Timeline
13 July 2018
Primary endpoint
30 June 2019
30 April 2020

Quick facts

Lead sponsorNorth District Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment53
Start date13 July 2018
Primary completion30 June 2019
Estimated completion30 April 2020
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

North District Hospital

Who can join

18 and older, any sex, with Hallux Valgus and Bunion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hallux Valgus Angle as a Measure of the Radiological Changes Primary · 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.

0 week
GroupValue95% CI
Control Rehab35.6± 7.1
Accelerated Rehab37.4± 8.0
12 week
GroupValue95% CI
Control Rehab8.8± 5.2
Accelerated Rehab7.2± 4.8
26 week
GroupValue95% CI
Control Rehab11.6± 7.6
Accelerated Rehab10.5± 6.2
Inter-metatarsal Angle as a Measure of the Radiological Changes Primary · 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.

0 week
GroupValue95% CI
Control Rehab14.0± 3.0
Accelerated Rehab16.4± 3.7
12 week
GroupValue95% CI
Control Rehab6.2± 1.9
Accelerated Rehab7.2± 2.2
26 week
GroupValue95% CI
Control Rehab7.7± 2.7
Accelerated Rehab7.3± 2.4
Radiological Changes (Tibial Sesamoid Position) Primary · 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.

0 week
GroupValue95% CI
Control Rehab5.55± 1.2
Accelerated Rehab5.6± 1.1
12 week
GroupValue95% CI
Control Rehab2.6± 1.2
Accelerated Rehab3.0± 0.9
26 week
GroupValue95% CI
Control Rehab2.9± 1.3
Accelerated Rehab3.0± 1.0
Foot Function (FAOS Symptoms) Secondary · 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.

0 week
GroupValue95% CI
Control 6-wk NWB58.3± 26.1
Early 2 Week NWB47.5± 23.9
12 week
GroupValue95% CI
Control 6-wk NWB62.1± 16.1
Early 2 Week NWB76.9± 13.6
26 week
GroupValue95% CI
Control 6-wk NWB81.9± 11.8
Early 2 Week NWB80.5± 15.6
Foot Function (FAOS Pain) Secondary · 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.

0 week
GroupValue95% CI
Control 6-wk NWB44± 23.8
Early 2 Week NWB47.5± 28.8
12 week
GroupValue95% CI
Control 6-wk NWB66.4± 19.3
Early 2 Week NWB78.6± 11.4
26 week
GroupValue95% CI
Control 6-wk NWB82.2± 15.6
Early 2 Week NWB85.5± 12.9
Foot Function (FAOS ADL) Secondary · 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.

0 week
GroupValue95% CI
Control 6-wk NWB59.7± 29.4
Early 2 Week NWB53.0± 25.6
12 week
GroupValue95% CI
Control 6-wk NWB61.4± 17.3
Early 2 Week NWB81.4± 7.6
26 week
GroupValue95% CI
Control 6-wk NWB84.3± 10.6
Early 2 Week NWB86.0± 8.2
Foot Function (FAOS Sport) Secondary · 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.

0 week
GroupValue95% CI
Control 6-wk NWB52.1± 29.7
Early 2 Week NWB39.8± 26.7
12 week
GroupValue95% CI
Control 6-wk NWBNA± NA
Early 2 Week NWBNA± NA
26 week
GroupValue95% CI
Control 6-wk NWB76.7± 15.7
Early 2 Week NWB77.6± 13.7
Foot Function (FAOS QoL) Secondary · 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.

0 week
GroupValue95% CI
Control 6-wk NWB41.2± 30.2
Early 2 Week NWB31.1± 23.6
12 week
GroupValue95% CI
Control 6-wk NWB49.1± 20.4
Early 2 Week NWB72.6± 20.7
26 week
GroupValue95% CI
Control 6-wk NWB82.4± 11.2
Early 2 Week NWB81.4± 14.9

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Randomised control trial on the optimal duration of non-weight-bearing walking after hallux valgus surgery.
    Ling SKK, Wu YM, Li C, Lui TH, et al · · 2020 · cited 8× · PMID 32489861 · DOI 10.1016/j.jot.2020.04.009

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03340415.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing