Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus

Completed

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

• Registration Number: NCT06625229
• Lead Sponsor: Orthopaedic and Arthritis Specialist Centre

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. 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

Not available

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-08-31
• Study First Submitted: 2024-09-20
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Manchester-Oxford Foot Questionnaire (MOXFQ)	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.	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.

Secondary Outcome Measures

Name	Time	Method
Complication Data	Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications	Complication data were routinely prospective collected for all patients until discharge and categorised using a modified Clavien-Dindo complication classification.
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).	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.
Radiographic Deformity Correction	Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)	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.
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).	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.

Trial Locations

Locations (1)

Orthopaedic and Arthritis Specialist Centre; 🇦🇺 Sydney, New South Wales, Australia