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Status unknownNCT05051709Updated Sep 21, 2021

Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

An interventional study of Corrective osteotomy and Fusion of First ray in Hallux Valgus, sponsored by Hawler Medical University. Status unknown at 1 site in Iraq. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hallux Valgus

Keywords

  • Hallux valgus
  • First ray hypermobility
  • Fusion
  • Corrective osteotomy
  • Functional outcome
03

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Hallux Valgus with 1st ray hypermobility

Exclusion criteria

Exclusion Criteria:

  1. Generalized Ligament laxity
  2. Previous foot and ankle surgery
  3. Diabetes Mellitus
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    Foot with no fusion

    Procedure: Corrective osteotomy

  • Active comparator
    Foot with fusion

    Procedure: Fusion of First ray

Interventions

  • ProcedureCorrective osteotomy

    First metatarsal distal corrective osteotomy

  • ProcedureFusion of First ray

    Fusion of first ray with soft tissue procedure

05

What researchers measure

Primary outcomes

  1. American foot and ankle score

    American foot and ankle score involved 9 section

    Time frame: This score was assessed one year after surgery

  2. Foot and Ankle Disability Index

    Foot and Ankle Disability Index involved 26 sections

    Time frame: This score was assessed one year after surgery

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — Later we will decide

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05051709
Lead sponsor
Hawler Medical University
Responsible party
Sherwan Ahmed Ali Hamawandi (Assistant professor of orthopedic surgery, Hawler Medical University) — Principal investigator
First posted
Sep 21, 2021
Start date
Sep 15, 2021 (estimated)
Primary completion
Sep 15, 2022 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Sep 21, 2021

Study contacts

Sherwan Hamawndi, Ass. prof.
Contact
sherwan.hamawandi@hmu.edu.krd
009644464321

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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