Actively Recruiting
Hallux Valgus - Radiological and Clinical Predictors for Outcome After Surgery
Led by Ostfold Hospital Trust · Updated on 2024-07-10
250
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clinical and radiological factors that may predict outcomes after surgery for hallux valgus (HV), a common adult forefoot deformity. The study focuses on understanding the deformity in three dimensions using new radiological parameters, aiming to improve insight into why current surgical techniques often have variable results and high recurrence rates. This prospective observational study seeks to address the lack of clear treatment guidelines and consensus for surgical intervention in HV. Participants accepted for corrective surgery for hallux valgus at Ostfold Hospital Trust will be invited to join the study. The study compares preoperative clinical data, patient-reported outcome measures (PROMs), and radiological parameters with postoperative assessments. Participants will be evaluated using the Manchester-Oxford Foot Questionnaire and radiological imaging before surgery and at 6 weeks, 12 weeks, and 52 weeks after surgery. During the study, participants will complete questionnaires and undergo radiological exams at specified intervals to track changes in foot function and deformity correction. The main outcome is comparing pre- and postoperative MOXFQ scores to assess patient-reported outcomes. Secondary measures include comparing traditional and newer rotational radiological parameters with PROMs. The study aims to include 200-250 participants and will monitor them for up to one year post-surgery.
CONDITIONS
Brief Title
Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults accepted for hallux valgus surgery (mild, moderate, severe) at Ostfold Hospital Trust
You will not qualify if you...
- Previous hallux valgus surgery on the same foot
- Lack of compliance
- Not available for follow-up
- Language difficulties (unable to communicate in English or Norwegian)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants undergo hallux valgus corrective surgery and receive immediate post-operative care.
1 surgery visit and approximately 1 post-operative visit
Duration - Up to 52 weeks
Participants are followed up to assess clinical and radiological outcomes after surgery.
Visits at 6 weeks, 12 weeks, and 52 weeks postoperatively
Trial Site Locations
Total: 1 location
1
Østfold Hospital Trust
Sarpsborg, Østfold fylke, Norway, 1714
Actively Recruiting
Research Team
M
Marius Molund, MD, PhD
M
Mikaela Engarås Hamre, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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