Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus

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.

Study Overview

• Status: Completed
• Conditions: Forefoot Surgery; Minimally Invasive Surgical Procedures; Minimally Invasive Surgical Technique; Hallux Valgus (Bunion) Resection; Hallux Abductovalgus; Hallux Deformity; Hallux Valgus Deformity; Hallux Valgus Surgery

• Study Type: Observational
• Enrollment (Actual): 483

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Orthopaedic and Arthritis Specialist Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting to a private surgeon in Sydney, Australia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Data	Complication data were routinely prospective collected for all patients until discharge and categorised using a modified Clavien-Dindo complication classification.	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)	A validated patient reported outcome measure for health related quality of life. The EQ-5D is a standardized patient-reported outcome measure (PROM) assessing health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, from no problems to extreme problems. The scores are combined into a health profile and converted into a single index value reflecting overall health, where 1 represents perfect health, 0 represents death, and negative values indicate health states worse than death. The EQ-5D also includes a visual analog scale (VAS) for patients to rate their overall health.	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	The intermetatarsal angle (IMA) and hallux valgus angle (HVA) were measured according to the American Orthopaedic Foot & Ankle Society technique and categorised with regards to deformity severity. pre-operatively, six months following surgery and final follow up. Round sign and sesamoid coverage were classified according to Okuda et al. and Yildirim et al.	Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)
Visual Analogue Scale for Pain (VAS Pain)	A validated outcome measure to assess pain. The Visual Analog Scale (VAS) for pain consists of a straight line with one end labeled no pain(0) and the other worst possible pain(100). Patients mark a point on the line that represents their pain level, and the distance from the no pain end to the mark is measured to quantify the pain. Higher scores indicate greater pain intensity, with 0 being no pain and 100 being the worst imaginable 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).

Collaborators and Investigators

• Sponsor: Orthopaedic and Arthritis Specialist Centre
• Investigators: Principal Investigator: Peter Lam, MBBS (Hons), FRACS,, Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Observational Study; patient reported outcome measure; Hallux valgus; minimally invasive surgery; Bunion; Osteotomy; percutaneous surgery; forefoot deformity; metatarsal osteotomy; Manchester Oxford Foot Questionnaire (MOXFQ)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Congenital Abnormalities; Hallux Valgus; Bunion
• Other Study ID Numbers: PLHV2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient consent not discussed for sharing of IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No