Hallux ValgusNCT04088214
Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
A study testing Arthroscopic lateral soft tissue release in people with Hallux Valgus and Hallux Valgus and Bunion, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Hallux Valgus and Bunion
- What is being tested?
- Arthroscopic lateral soft tissue release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- >18 and legally fit for consent
- Symptomatic hallux valgus with HVA >15 degrees
Who cannot join
- Active physical or mental disorders that could affect rehabilitation including
- Other conditions affecting ambulation: lower limb injury, neuromuscular problems etc.
- Mental incapacitation
- Previous hallux valgus surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Series Regarding the Efficacy of the Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.
- Conditions
- Hallux Valgus, Hallux Valgus and Bunion
- Being tested
- Arthroscopic lateral soft tissue release
- Keywords
- Arthroscopy
- 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.
Arthroscopic lateral soft tissue releaseProcedure or surgery
The arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy.
| Study group | Role | What they receive |
|---|---|---|
| ArtDSTP | Experimental | Arthroscopic lateral soft tissue release Receives: Procedure: Arthroscopic lateral soft tissue release |
What is being measured
The primary outcome is the main question the study is designed to answer.
HVA
- Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Measured: 12 weeks post-surgery
HVA
- Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Measured: 52 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Jan 2018
- Primary completion1 Apr 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- case series
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
- Investigators
- Samuel KK Ling, MBChB, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088214
- Sponsor's protocol ID
- NTEC-2019-0340
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series Regarding the Efficacy of the Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
- ClinicalTrials.gov ID
- NCT04088214
- Acronym / sponsor ID
- NTEC-2019-0340
- Conditions
- Hallux Valgus, Hallux Valgus and Bunion
- Keywords
- Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series
| Arm | Type | Receives |
|---|---|---|
| ArtDSTP | Experimental | Procedure: Arthroscopic lateral soft tissue releaseArthroscopic lateral soft tissue release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 and legally fit for consent
- Symptomatic hallux valgus with HVA >15 degrees
Key exclusion criteria (4 listed)
- Active physical or mental disorders that could affect rehabilitation including
- Previous hallux valgus surgery
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 |
|---|---|---|
| Arthroscopic lateral soft tissue releaseThe arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy. | Procedure or surgery | ArtDSTP |
Primary outcome
HVA
Time frame: 12 weeks post-surgery
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
HVA
Time frame: 52 weeks post-surgery
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- 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
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic lateral soft tissue release in people with Hallux Valgus and Hallux Valgus and Bunion, run by Chinese University of Hong Kong 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 2 inclusion and 4 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 12 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HVA (time frame: 12 weeks post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2019.