Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus

NCT06625229 | Completed

• 1 other identifier: PLHV2024
• Study Type: observational
• Target: 483
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Bunion; Hallux valgus; percutaneous surgery; minimally invasive surgery; forefoot deformity; metatarsal osteotomy; patient reported outcome measure; Manchester Oxford Foot Questionnaire (MOXFQ); Osteotomy; Observational Study

Outcome Measures

Primary Outcomes (1)

• Manchester-Oxford Foot Questionnaire (MOXFQ)

  A validated patient reported outcome measure for assessment of function in hallux valgus. The Manchester Oxford Foot Questionnaire (MOXFQ) consists of 3 domains (walking and standing, social interaction \[based on the patient's self-consciousness regarding their feet/shoes as well as the overall impact on social, recreational, work, and other everyday activities\], and pain), with the score in each domain ranging from 0 (best possible score) to 100 (worst possible score). An overall summary "index" score can also be calculated. The minimal clinically important difference (MCID) has been shown to be 16, 12, and 24 for the walking and standing, pain, and social interaction domains, respectively.

  Patients completed the MOXFQ at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up.

Secondary Outcomes (4)

• Complication Data

  Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications

• EuroQol 5D Health Related Quality of Life (EQ-5D)

  Patients completed the EQ5D at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).

• Radiographic Deformity Correction

  Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)

• Visual Analogue Scale for Pain (VAS Pain)

  Patients completed the VAS Pain at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting to a private surgeon in Sydney, Australia

You may qualify if:

• Primary diagnosis of hallux valgus that has failed conservative treatment

You may not qualify if:

• Degenerative changes of first MTPJ
• Previous hallux valgus deformity correction surgery

Sponsors & Collaborators

• Orthopaedic and Arthritis Specialist Centre: lead

Study Sites (1)

Orthopaedic and Arthritis Specialist Centre

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Officials

• Peter Lam, MBBS (Hons), FRACS,

  Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 3, 2024
• Study Start: November 1, 2017
• Primary Completion: January 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)