The HYALEX Pivotal Study
Part of paid clinical trials in La Mesa, California.
- Sponsor
- Hyalex Orthopaedics, Inc.
- Study ID
- NCT06368700
- Status
- Recruiting
Conditions
- Damaged Chondral or Osteochondral Area
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Hyalex Knee Cartilage System — DEVICESurgical implantation of the Hyalex Knee Cartilage System
Study Details
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
Key Dates
- Start date
- Apr 4, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 85 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: HYALEX Freestyle Resurfacing SystemImplantation of the HYALEX Implant
Primary Outcome Measure
Composite Primary Endpoint [ Time Frame: 12 months ]
Central Contacts
- Chris Cain408-439-5154
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Horizon Clinical Research | La Mesa | California | 91942 | Scott Hacker, M.D. (PRINCIPAL_INVESTIGATOR) |
| Ochsner Sports Medicine Institute | New Orleans | Louisiana | 70121 | Brian Godshaw, M.D. (PRINCIPAL_INVESTIGATOR) |
| Hospital for Special Surgery | New York | New York | 10021 | Sabrina Strickland, M.D. (PRINCIPAL_INVESTIGATOR) Andreas Gomoll, M.D. (SUB_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | Dennis Crawford, M.D. (PRINCIPAL_INVESTIGATOR) |