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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has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.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
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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

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Keywords

  • Hallux valgus
  • First ray hypermobility
  • Fusion
  • Corrective osteotomy
  • Functional outcome
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In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 15 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
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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

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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

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Study locations

1 of 1 sites recruiting
  • Hawler Medica University
    Erbil, 44001, Iraq
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided — Later we will decide

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2021; primary completion for Sep 2022, 12 months later.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 12 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2021
First posted
Sep 21, 2021
StartEst.
Sep 15, 2021
Primary completionEst.
Sep 15, 2022
CompletionEst.
Sep 15, 2023
Last update
Sep 21, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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