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Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Corrective osteotomy
Fusion of First ray
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Hallux valgus, First ray hypermobility, Fusion, Corrective osteotomy, Functional outcome

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hallux Valgus with 1st ray hypermobility

Exclusion Criteria:

  1. Generalized Ligament laxity
  2. Previous foot and ankle surgery
  3. Diabetes Mellitus

Sites / Locations

  • Hawler Medica UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Foot with no fusion

Foot with fusion

Arm Description

Outcomes

Primary Outcome Measures

American foot and ankle score
American foot and ankle score involved 9 section
Foot and Ankle Disability Index
Foot and Ankle Disability Index involved 26 sections

Secondary Outcome Measures

Full Information

First Posted
September 11, 2021
Last Updated
September 11, 2021
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05051709
Brief Title
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus
Official Title
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Hallux valgus, First ray hypermobility, Fusion, Corrective osteotomy, Functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foot with no fusion
Arm Type
Active Comparator
Arm Title
Foot with fusion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Corrective osteotomy
Intervention Description
First metatarsal distal corrective osteotomy
Intervention Type
Procedure
Intervention Name(s)
Fusion of First ray
Intervention Description
Fusion of first ray with soft tissue procedure
Primary Outcome Measure Information:
Title
American foot and ankle score
Description
American foot and ankle score involved 9 section
Time Frame
This score was assessed one year after surgery
Title
Foot and Ankle Disability Index
Description
Foot and Ankle Disability Index involved 26 sections
Time Frame
This score was assessed one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hallux Valgus with 1st ray hypermobility Exclusion Criteria: Generalized Ligament laxity Previous foot and ankle surgery Diabetes Mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherwan Hamawndi, Ass. prof.
Phone
009644464321
Email
sherwan.hamawandi@hmu.edu.krd
Facility Information:
Facility Name
Hawler Medica University
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherwan Hamawandi, Ass.Prof.
Phone
009647504464321
Email
sherwan.hamawandi@hmu.edu.krd

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Later we will decide

Learn more about this trial

Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

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