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 range18 Years – 75 Years
SexALL
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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…