Actively Recruiting
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
Led by Tom Lootens · Updated on 2025-03-12
99
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand whether treating cartilage damage at the first metatarsophalangeal (MTP I) joint during surgery for hallux valgus affects patient outcomes. Currently, there are no clear guidelines about managing these cartilage lesions, and it is unknown if treatment impacts recovery or satisfaction after surgery. The study randomly assigns patients into groups based on the presence and severity of cartilage lesions found during surgery. One group includes patients with no or mild lesions who receive no treatment for cartilage damage. Patients with more severe lesions are randomly divided to either receive treatment involving debridement and microfracture of the cartilage or no treatment for these lesions. The surgery and treatment decisions are managed by a single surgeon using imaging tools to assess lesion severity. Participants will be evaluated before surgery and asked to complete questionnaires about pain, function, and satisfaction. Follow-up visits occur at 10 days, 5 weeks, 4 months, and 1 year after surgery to monitor clinical outcomes and repeat questionnaires. The study measures changes in foot function scores, general health, pain levels, and patient satisfaction over time, with a blinded investigator performing follow-ups to ensure unbiased assessments.
CONDITIONS
Brief Title
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hallux valgus
You will not qualify if you...
- Younger than 30 years or older than 60 years
- Presence of other foot or health problems besides hallux valgus
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.
1 visit (in-person) at the outpatient clinic for informed consent and initial assessments
Duration - Day of surgery
Participants undergo hallux valgus corrective surgery. During surgery, cartilage lesions are assessed and treated based on randomization.
1 visit (in-person) for the surgical procedure
Duration - 1 year
Participants return for clinical follow-up and complete questionnaires to assess clinical outcomes after surgery.
4 visits (in-person) at 10 days, 5 weeks, 4 months, and 1 year postoperatively
Trial Site Locations
Total: 1 location
1
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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