Hallux Valgus and BunionNCT03340415
Timing of Weight Bearing After Hallux Valgus Surgery
A study testing Accelerated Rehabilitation plan in people with Hallux Valgus and Bunion, run by North District Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- Accelerated Rehabilitation plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Jul 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing the EDSTP recruited
Who cannot join
- Cases requiring additional procedures (eg 2nd toe correction)
- Mental incapacitation
- Physical disability hindering rehabilitation (eg CVA, neurological disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
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.
Read the 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
- Conditions
- Hallux Valgus and Bunion
- Being tested
- Accelerated Rehabilitation plan
- Keywords
- Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Rehabilitation planOther
early weight bearing after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Accelerated Rehabilitation plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0, 12, 26 weeks post-surgery
Secondary outcomes (5)
Foot Function (FAOS Symptoms)
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.
Measured: 0, 12, 26 week post-surgery
Foot Function (FAOS Pain)
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.
Measured: 0, 12, 26 week post-surgery
Foot Function (FAOS ADL)
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.
Measured: 0, 12, 26 week post-surgery
Foot Function (FAOS Sport)
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.
Measured: 0, 12, 26 week post-surgery
Foot Function (FAOS QoL)
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.
Measured: 0, 12, 26 week post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start13 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus and BunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- North District Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
- Investigators
- Samuel KK Ling, MBChB, Principal investigator, Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340415
- Sponsor's protocol ID
- HVrehab
- Status last verified
- Mar 2021
- First submitted
- 7 Nov 2017
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26752780Lui 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.
PubMed 28580264Lui 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.
PubMed 16325100Lui 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.
PubMed 20678710
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT03340415
- Acronym / sponsor ID
- HVrehab
- Conditions
- Hallux Valgus and Bunion
- Keywords
- Hallux Valgus, Bunion, Post-operative, Rehabilitation, Weight Bearing Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- North District HospitalUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Accelerated Rehabilitation planAccelerated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing the EDSTP recruited
Key exclusion criteria (3 listed)
- Cases requiring additional procedures (eg 2nd toe correction)
- Mental incapacitation
- Physical disability hindering rehabilitation (eg CVA, neurological disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Rehabilitation planearly weight bearing after surgery | Other | Accelerated Rehab |
Primary outcome
Hallux Valgus Angle as a Measure of the Radiological Changes
Time frame: 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.
Inter-metatarsal Angle as a Measure of the Radiological Changes
Time frame: 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.
Radiological Changes (Tibial Sesamoid Position)
Time frame: 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.
5 secondary outcomes
Foot Function (FAOS Symptoms)
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS Pain)
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS ADL)
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS Sport)
Time frame: 0, 12, 26 week post-surgery
Foot Function (FAOS QoL)
Time frame: 0, 12, 26 week post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26752780Lui 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.
- Results publication: PubMed 28580264Lui 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.
- Results publication: PubMed 16325100Lui 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.
- Results publication: PubMed 20678710Lui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel KK Ling, MBChB principal investigator
Dept of Orthopaedics & Traumatology, the Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Rehabilitation plan in people with Hallux Valgus and Bunion, run by North District Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux Valgus Angle as a Measure of the Radiological Changes (time frame: 0, 12, 26 weeks post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340415, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.