Degenerative Joint Disease of the Hip Clinical Trial
Official title:
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
| Verified date | May 2016 |
| Source | Biomimedica, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Dutch Health Care Inspectorate |
| Study type | Interventional |
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement - Skeletally mature or at least 18 years of age and has normal anatomy - Patient signs the Informed Consent form - Failed medical management - There will be size limitations on patients also - available size range is 46mm-54mm. Exclusion Criteria: - Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components - Previous fusion, acute femoral neck fracture and/or above knee amputation - Revision of any previous hip procedure - Slipped capital femoral epiphysis (SCFE) - Rheumatoid arthritis - AVN |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Rijnstate Arnhem | Arnhem |
| Lead Sponsor | Collaborator |
|---|---|
| Biomimedica, Inc |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events | 6 months | Yes |