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

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

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.

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