Back to resultsA 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
Primary Purpose
Degenerative Joint Disease of the Hip
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
GRADION™ Hip Total Cartilage Replacement (TCR)™
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Joint Disease of the Hip
Eligibility Criteria
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
Sites / Locations
- Rijnstate Arnhem
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GRADION™ Hip Total Cartilage Replacement (TCR)™
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01982266
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Device failure
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomimedica, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease of the Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRADION™ Hip Total Cartilage Replacement (TCR)™
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
GRADION™ Hip Total Cartilage Replacement (TCR)™
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rijnstate Arnhem
City
Arnhem
ZIP/Postal Code
6815
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
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
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