The Hyalex MTP Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorHyalex Orthopaedics, Inc.
About this trial
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.
Eligibility criteria
Qualifiers
21-75 years;
Body Mass Index (BMI) ≤ 38;
Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4;
Pre-operative VAS pain score of >40;
Disqualifiers
Known allergy to polyurethanes, bone cement, acrylic, or titanium;
Due to anatomy and/or lesion location, inability to position the implant flush or slightly proud relative to the articular surface precluding proper device placement;
Lack of 2mm of vital bone on all sides of implant site;
Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment;
Trial design
Treatments tested in this trial
- MTP Hemiarthroplasty
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov