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NCT01982266 Clinical Trial

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

Degenerative Joint Disease of the Hip Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01982266
Other study ID # EP052
Secondary ID
Status Terminated
Phase N/A
First received November 1, 2013
Last updated May 16, 2016
Start date November 2013
Est. completion date August 2014

Study information
Verified date May 2016
Source Biomimedica, Inc
Contact n/a
Is FDA regulated No
Health authority Netherlands: Dutch Health Care Inspectorate
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Rijnstate Arnhem Arnhem

Sponsors (1)
Lead Sponsor Collaborator
Biomimedica, Inc

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events 6 months Yes