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

http://clinicaltrials.gov/ct2/show/NCT01982266

Purpose

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. Condition Intervention Degenerative Joint Disease of the Hip
Device: GRADION Hip Total Cartilage Replacement (TCR
Study Type: Interventional Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment 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 Primary Outcome Measures:

• Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15 Study Start Date: November 2013 Estimated Study Completion Date: June 2015 Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure) Eligibility
Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No 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

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01982266 Locations Netherlands Rijnstate Arnhem Recruiting Arnhem, Netherlands, 6815 Contact: JLC van Susante, Dr.     088-0058888         Principal Investigator: JLC van Susante, Dr.             Sponsors and Collaborators Biomimedica, Inc