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
Not Applicable
Terminated
- Conditions
- Degenerative Joint Disease of the Hip
- Interventions
- Device: GRADION™ Hip Total Cartilage Replacement (TCR)™
- Registration Number
- NCT01982266
- Lead Sponsor
- Biomimedica, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GRADION™ Hip Total Cartilage Replacement (TCR)™ GRADION™ Hip Total Cartilage Replacement (TCR)™ -
- Primary Outcome Measures
Name Time Method Adverse events 6 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of cartilage regeneration in GRADION™ Hip TCR™ trials?
How does GRADION™ Hip TCR™ compare to standard hip resurfacing in degenerative joint disease outcomes?
Which biomarkers correlate with successful cartilage replacement using GRADION™ Hip TCR™ in hip OA patients?
What adverse events were observed in early-stage GRADION™ Hip TCR™ feasibility studies and how were they managed?
Are there any combination therapies or competitor devices for hip cartilage replacement similar to GRADION™ TCR™?
Trial Locations
- Locations (1)
Rijnstate Arnhem
🇳🇱Arnhem, Netherlands
Rijnstate Arnhem🇳🇱Arnhem, Netherlands