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, Inc1 site in 1 country4 target enrollmentNovember 2013

ConditionsDegenerative Joint Disease of the Hip

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Joint Disease of the Hip
Sponsor: Biomimedica, Inc
Enrollment: 4
Locations: 1
Primary Endpoint: Adverse events
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

August 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biomimedica, Inc

Responsible Party

Sponsor

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