Hallux ValgusNCT05051709
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus
A study testing Corrective osteotomy and Fusion of First ray in people with Hallux Valgus, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Corrective osteotomy and Fusion of First ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIraq
- Study dates
- 15 Sep 2021to 15 Sep 2023
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hallux Valgus with 1st ray hypermobility
Who cannot join
- Generalized Ligament laxity
- Previous foot and ankle surgery
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Hawler Medica University
Erbil, 44001
Sherwan Hamawandi, Ass.Prof., 009647504464321, sherwan.hamawandi@hmu.edu.krd
About this study
Official title: Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus: Randomized Control Trial
Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.
- Conditions
- Hallux Valgus
- Being tested
- Corrective osteotomy, Fusion of First ray
- Keywords
- Hallux valgus, First ray hypermobility, Fusion, Corrective osteotomy, Functional outcome
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrective osteotomyProcedure or surgery
First metatarsal distal corrective osteotomy
Fusion of First rayProcedure or surgery
Fusion of first ray with soft tissue procedure
| Study group | Role | What they receive |
|---|---|---|
| Foot with no fusion | Active comparator | Not described Receives: Procedure: Corrective osteotomy |
| Foot with fusion | Active comparator | Not described Receives: Procedure: Fusion of First ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
American foot and ankle score
American foot and ankle score involved 9 section
Measured: This score was assessed one year after surgery
Foot and Ankle Disability Index
Foot and Ankle Disability Index involved 26 sections
Measured: This score was assessed one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Sep 2021 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2023 (estimated)
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.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051709
- Sponsor's protocol ID
- HMU/Sherwan12
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Later we will decide
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05051709
- Acronym / sponsor ID
- HMU/Sherwan12
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, First ray hypermobility, Fusion, Corrective osteotomy, Functional outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 21 Sep 2021 (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.
Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot with no fusion | Active comparator | Procedure: Corrective osteotomy |
| Foot with fusion | Active comparator | Procedure: Fusion of First ray |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hallux Valgus with 1st ray hypermobility
Key exclusion criteria (3 listed)
- Generalized Ligament laxity
- Previous foot and ankle surgery
- Diabetes Mellitus
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 |
|---|---|---|
| Corrective osteotomyFirst metatarsal distal corrective osteotomy | Procedure or surgery | Foot with no fusion |
| Fusion of First rayFusion of first ray with soft tissue procedure | Procedure or surgery | Foot with fusion |
Primary outcome
American foot and ankle score
Time frame: This score was assessed one year after surgery
American foot and ankle score involved 9 section
Foot and Ankle Disability Index
Time frame: This score was assessed one year after surgery
Foot and Ankle Disability Index involved 26 sections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: Undecided. Later we will decide
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrective osteotomy and Fusion of First ray in people with Hallux Valgus, run by Hawler Medical University at 1 site in Iraq.
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: status not confirmed, as of the sponsor's last update on 21 Sep 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 Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherwan Hamawndi, Ass. prof. (009644464321, sherwan.hamawandi@hmu.edu.krd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American foot and ankle score (time frame: This score was assessed one year after 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 21 Sep 2021.