Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Rand… (NCT05518721) | Clinical Trial Compass
WithdrawnNot Applicable
Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial
Stopped: Original PI left institution and successor has no interest in continuing project.
United States0Started 2022-07-05
Plain-language summary
A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals must be older than 18 and younger than 75 years of age, both genders.
* Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
* Clinical and radiographical clinical diagnosis of hallux rigidus.
* Hallux Rigidus grade III or grade IV.
* Surgical indication after failure of nonoperative treatment (at least six months).
Exclusion Criteria:
* Previous hallux metatarsophalangeal fusion.
* Less than 20 degrees of complete range of motion on the hallux metatarsophalangeal joint.
* Patient desire or medical indication for a hallux metatarsophalangeal joint arthrodesis.
* Patient desire or medical indication for other surgical modalities.
* History or documented evidence of autoimmune or peripheral vascular diseases.
* History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.).
* Any condition that represents a contraindication of the proposed therapies.
* Any physical or social limitation that makes the protocol continuation unviable.
* Impossibility or incapacity to sign the informed Consent Form.
* Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
* Pregnancy.
* Clinical and imaging diagnosis of untreated osteoporosis.
* Serum vitamin D levels below 20ng/ml.
* No…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.