Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

September 11, 2021 updated by: Sherwan Ahmed Ali Hamawandi, Hawler Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Erbil, Iraq, 44001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hallux Valgus with 1st ray hypermobility

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Foot with no fusion
Procedure: Corrective osteotomy
First metatarsal distal corrective osteotomy
Active Comparator: Foot with fusion
Procedure: Fusion of First ray
Fusion of first ray with soft tissue procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American foot and ankle score
Time Frame: This score was assessed one year after surgery
American foot and ankle score involved 9 section
This score was assessed one year after surgery
Foot and Ankle Disability Index
Time Frame: This score was assessed one year after surgery
Foot and Ankle Disability Index involved 26 sections
This score was assessed one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

September 11, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMU/Sherwan12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Later we will decide

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hallux Valgus

Clinical Trials on Corrective osteotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe