Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

NCT ID: NCT05051709

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Foot with no fusion

Group Type ACTIVE_COMPARATOR

Corrective osteotomy

Intervention Type PROCEDURE

First metatarsal distal corrective osteotomy

Foot with fusion

Group Type ACTIVE_COMPARATOR

Fusion of First ray

Intervention Type PROCEDURE

Fusion of first ray with soft tissue procedure

Interventions

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Corrective osteotomy

First metatarsal distal corrective osteotomy

Intervention Type PROCEDURE

Fusion of First ray

Fusion of first ray with soft tissue procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Hallux Valgus with 1st ray hypermobility

Exclusion Criteria

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

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hawler Medica University

Erbil, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Sherwan Hamawndi, Ass. prof.

Role: CONTACT

009644464321

Facility Contacts

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Sherwan Hamawandi, Ass.Prof.

Role: primary

009647504464321

Other Identifiers

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HMU/Sherwan12

Identifier Type: -

Identifier Source: org_study_id

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