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.

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Key information

Conditions

Hallux Valgus Deformity Bunion Foot Deformities Foot Deformities, Acquired Forefoot Surgery Hallux Abductovalgus Hallux Deformity Hallux Valgus Hallux Valgus (Bunion) Resection Hallux Valgus Surgery Minimally Invasive Surgical Procedures Minimally Invasive Surgical Technique Musculoskeletal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic and Arthritis Specialist Centre

Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Manchester-Oxford Foot Questionnaire (MOXFQ)

Time frame: 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 outcomes

Complication Data

Time frame: 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)

Time frame: 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

Time frame: 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 &amp;amp;amp; 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orthopaedic and Arthritis Specialist Centre

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Oct 3, 2024
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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