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

Completed

• Conditions: Noninflammatory Degenerative Joint Disease; osteoarthritis; 10023213; 10005944

• Registration Number: NL-OMON38645
• Lead Sponsor: Biomimedica, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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 -52mm.

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 femoral capital epiphysis (SCFE)
• Rheumatoid arthritis
• AVN
• Active infection, tumor, or multiple cysts
• Biomechanically compromised (e.g. coxa valga, coxa vara, Legg-Calve-Perthes, hip dyspasia)
• Women who are pregnant; if of child bearing years, must have a negative serum βHCG within 24 hours of procedure
• Impingement
• Neurological or musculoskeletal disease that may adversely affect gait or weight bearing
• Previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
• Active hepatitis or HIV infection
• Prisoners
• Body Mass Index (BMI) of >35
• Neuropathic joints
• Severe documented psychiatric disease
• Require structural bone grafts
• Ipsilateral girdlestone
NOTE: In cases of questionable bone stock, a Dual-Energy X-ray Absorptiometry (DEXA) scan may be necessary to assess inadequate bone stock.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to demonstrate the safety of the<br /><br>investigational device GRADION* Hip Total Cartilage Replacement (TCR)*. This<br /><br>will be assessed by adverse events at 6 and 12 months.</p><br>