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NCT05518721
Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial
NA trial testing Hallux Rigidus Treatment in Hallux Rigidus. Withdrawn.
14 December 2023
Quick facts
| Lead sponsor | John Femino |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 5 July 2022 |
| Primary completion | 14 December 2023 |
| Estimated completion | 14 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hallux Rigidus Treatment
Conditions studied
- Hallux Rigidus — all drugs for Hallux Rigidus →
Sponsor
John Femino
Who can join
Adults 18 to 75, any sex, with Hallux Rigidus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05518721
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hallux Rigidus
Currently open trials in the same condition.
- NCT05555459 — Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation · NA · recruiting
- NCT05795127 — Risk for Reoperation After First MTP Joint Arthrodesis · active not recruiting
- NCT04590313 — Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus · NA · active not recruiting
- NCT04473196 — The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion · NA · recruiting
Other John Femino trials
Trials by the same sponsor.
- NCT05562154 — Lateral Approach Versus Anterior Approach in Total Ankle Replacement · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05518721 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by John Femino
- Last refreshed: 20 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05518721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing