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Not yet recruitingNCT06584487Updated Sep 4, 2024

Proximal Metatarsal Osteotomy in Correction of Hallux Valgus

An observational study in Hallux Valgus and Bunion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-04.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
15
Ages
15 Years and older
Sex
All
01

Study summary

The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy

Read the detailed description

Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population, which often requires surgical treatment when nonsurgical treatments fail.

During the past decades, multiple modified procedures and fixation techniques have been described.

The most common types of osteotomies of the first metatarsal are crescentic, chevron, scarf and lateral or medial opening wedge techniques.

A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0% and 20%.

On the other side, the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure. The proximal location of the osteotomy avoids devascularization of the metatarsal head, and the crescent shape maintains the length of the metatarsal. It allows a high degree of correction at the intermetatarsal angle in severe deformities.

When the condition is associated with an increased intermetatarsal angle, a surgical technique using a proximal first metatarsal osteotomy is often indicated. A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable, reliable means to correct the increased intermetatarsal angle.

Over the past 10 years, some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal. In addition, fixation with a plate has been described as technically less challenging.

02

Conditions studied

  • Hallux Valgus and Bunion

Keywords

  • Proximal Osteotomy
  • Medial Opening Wedge
  • Hallux Valgus
03

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 60 across 35 observational studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All patient above 15 years old

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

  • all admitted patients to Assiut University Hospitals.
  • age group of 15 years old and above.
  • Moderate and severe degrees of hallux valgus.

Exclusion criteria

Exclusion Criteria:

  • Burn
  • age group below 15 years old.
  • patient who refuse to participate in the study.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).

    Pain-Function-Alignment

    Time frame: baseline

Secondary outcomes

  1. Post operative radiographic changes in standing AP view foot and standing lateral view foot.

    In standing AP view foot * The hallux valgus angle HVA in degrees.It is the angle between long axis of 1st metatarsal and proximal phalanx of big toe * The intermetatarsal angle IMA in degree * The distal metatarsal articular angle DMAA in degree * The 1st metatarsal length in centimeter In standing lateral view foot * The inclination angle of the 1st metatarsal in degree In standing AP view foot * The hallux valgus angle HVA in degree * The intermetatarsal angle IMA in degree * The distal metatarsal articular angle DMAA in degree * The 1st metatarsal length in centimeter In standing lateral view foot * The inclination angle of the 1st metatarsal

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Markbreiter LA, Thompson FM. Proximal metatarsal osteotomy in hallux valgus correction: a comparison of crescentic and chevron procedures. Foot Ankle Int. 1997 Feb;18(2):71-6. doi: 10.1177/107110079701800205. PubMed 9043877 ↗
  • Saragas NP. Proximal opening-wedge osteotomy of the first metatarsal for hallux valgus using a low profile plate. Foot Ankle Int. 2009 Oct;30(10):976-80. doi: 10.3113/FAI.2009.0976. PubMed 19796591 ↗
  • Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available. PubMed 16049235 ↗
  • Okuda R, Kinoshita M, Yasuda T, Jotoku T, Shima H. Proximal metatarsal osteotomy for hallux valgus: comparison of outcome for moderate and severe deformities. Foot Ankle Int. 2008 Jul;29(7):664-70. doi: 10.3113/FAI.2008.0664. PubMed 18785415 ↗
  • Thordarson DB, Leventen EO. Hallux valgus correction with proximal metatarsal osteotomy: two-year follow-up. Foot Ankle. 1992 Jul-Aug;13(6):321-6. doi: 10.1177/107110079201300605. PubMed 1398360 ↗

Individual participant data

Plan to share: Undecided

09

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 Oct 2024; primary completion for Sep 2025, 11 months later.

Of 15 observational studies under Hallux Valgus, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 62. This study's planned 11 months is below that.

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

Registered
Aug 14, 2024
First posted
Sep 4, 2024
StartEst.
Oct 10, 2024
Primary completionEst.
Sep 2025
CompletionEst.
Oct 2025
Last update
Sep 4, 2024
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 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06584487
Lead sponsor
Assiut University
Responsible party
Abdulrahman Mahdi Hussein Mohamed (Resident, Assiut University) — Principal investigator
First posted
Sep 4, 2024
Start date
Oct 10, 2024 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Sep 4, 2024

Study contacts

Abdulrahman M Hussein Mohamed, Master
Contact
Abd-Elrahman.20134151@med.aun.edu.eg
+2001063555610
Abdulrahman M Hussein Mohamed
principal investigator · Assiut University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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