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NCT05051709 Clinical Trial

Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

Hallux Valgus Clinical Trial

Official title:
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus: Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05051709
Other study ID # HMU/Sherwan12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date September 15, 2023

Study information
Verified date September 2021
Source Hawler Medical University
Contact Sherwan Hamawndi, Ass. prof.
Phone 009644464321
Email sherwan.hamawandi@hmu.edu.krd
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date September 15, 2023
Est. primary completion date September 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - Hallux Valgus with 1st ray hypermobility Exclusion Criteria: 1. Generalized Ligament laxity 2. Previous foot and ankle surgery 3. Diabetes Mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Corrective osteotomy
First metatarsal distal corrective osteotomy
• Fusion of First ray
Fusion of first ray with soft tissue procedure

Locations
Country Name City State
Iraq Hawler Medica University Erbil

Sponsors (1)
Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Primary American foot and ankle score American foot and ankle score involved 9 section This score was assessed one year after surgery
Primary Foot and Ankle Disability Index Foot and Ankle Disability Index involved 26 sections This score was assessed one year after surgery
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