Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus

NCT ID: NCT06625229

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-08-31

Brief Summary

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The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are:

1. What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery
2. What severity of bunion deformity can be corrected with minimally invasive surgery
3. What factors may lead to recurrence of bunion deformity
4. What is the rate of complications following bunion deformity surgery

Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.

Detailed Description

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Conditions

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Hallux Valgus Deformity Hallux Valgus (Bunion) Resection Hallux Valgus Surgery Hallux Deformity Forefoot Surgery Minimally Invasive Surgical Procedures Minimally Invasive Surgical Technique Hallux Abductovalgus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive patients

Consecutive patients aged 16 years and over, who had exhausted conservative treatment and subsequently underwent primary correction of hallux valgus (of any deformity severity) were included. Patients who underwent additional forefoot procedures eg. hammer toe corrections, distal metaphyseal metatarsal osteotomy, were included. Patients who had previously had hallux valgus surgery, or first ray degenerative joint disease were excluded.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of hallux valgus that has failed conservative treatment

Exclusion Criteria

* Degenerative changes of first MTPJ
* Previous hallux valgus deformity correction surgery
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic and Arthritis Specialist Centre

OTHER

Sponsor Role lead

Responsible Party

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Thomas Lewis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Lam, MBBS (Hons), FRACS,

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia

Locations

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Orthopaedic and Arthritis Specialist Centre

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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PLHV2024

Identifier Type: -

Identifier Source: org_study_id

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