NCT05051709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 11, 2021

Last Update Submit

September 11, 2021

Conditions

Hallux Valgus

Keywords

Hallux valgusFirst ray hypermobilityFusionCorrective osteotomyFunctional outcome

Outcome Measures

Primary Outcomes (2)

  • American foot and ankle score

    American foot and ankle score involved 9 section

    This score was assessed one year after surgery

  • Foot and Ankle Disability Index

    Foot and Ankle Disability Index involved 26 sections

    This score was assessed one year after surgery

Study Arms (2)

Foot with no fusion

ACTIVE COMPARATOR
Procedure: Corrective osteotomy

Foot with fusion

ACTIVE COMPARATOR
Procedure: Fusion of First ray

Interventions

Corrective osteotomyPROCEDURE

First metatarsal distal corrective osteotomy

Foot with no fusion
Fusion of First rayPROCEDURE

Fusion of first ray with soft tissue procedure

Foot with fusion

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hallux Valgus with 1st ray hypermobility

You may not qualify if:

  • Generalized Ligament laxity
  • Previous foot and ankle surgery
  • Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawler Medica University

Erbil, 44001, Iraq

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Central Study Contacts

Sherwan Hamawndi, Ass. prof.

CONTACT

009644464321sherwan.hamawandi@hmu.edu.krd

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of orthopedic surgery

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 21, 2021

Study Start

September 15, 2021

Primary Completion

September 15, 2022

Study Completion

September 15, 2023

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

IR(1)