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

Biomimedica

Status: Terminated

Conditions: Degenerative Joint Disease of the Hip

Treatments: Device: GRADION™ Hip Total Cartilage Replacement (TCR)™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982266

EP052

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

GRADION™ Hip Total Cartilage Replacement (TCR)™

Experimental group

Treatment:

Device: GRADION™ Hip Total Cartilage Replacement (TCR)™