Clinical trial NCT06625229: Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
Official title: Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Orthopaedic and Arthritis Specialist Centre
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 483
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients presenting to a private surgeon in Sydney, Australia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Manchester-Oxford Foot Questionnaire (MOXFQ)
timeFrame: 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:
measure: Complication Data
timeFrame: Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications
measure: EuroQol 5D Health Related Quality of Life (EQ-5D)
timeFrame: 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).
measure: Radiographic Deformity Correction
timeFrame: Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)
measure: Visual Analogue Scale for Pain (VAS Pain)
timeFrame: 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).
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Orthopaedic and Arthritis Specialist Centre
state: New South Wales
Study officials:
affiliation: Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia
name: Peter Lam, MBBS (Hons), FRACS,
role: PRINCIPAL_INVESTIGATOR
References: