NCT06584487

Brief Summary

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

Trial Health

35
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 all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

August 14, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

August 14, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

Proximal OsteotomyMedial Opening WedgeHallux Valgus

Outcome Measures

Primary Outcomes (1)

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

    Pain-Function-Alignment

    baseline

Secondary Outcomes (1)

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

    Baseline

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient above 15 years old

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 9043877BACKGROUND
  • 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.

    PMID: 19796591BACKGROUND
  • 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.

    PMID: 16049235BACKGROUND
  • 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.

    PMID: 18785415BACKGROUND
  • 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.

    PMID: 1398360BACKGROUND

MeSH Terms

Conditions

Hallux ValgusBunion

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesFoot Deformities, Acquired

Study Officials

  • Abdulrahman M Hussein Mohamed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman M Hussein Mohamed, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 14, 2024

First Posted

September 4, 2024

Study Start

October 10, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 4, 2024

Record last verified: 2024-09