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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Joint Disease of the Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GRADION™ Hip Total Cartilage Replacement (TCR)™

Group Type EXPERIMENTAL

GRADION™ Hip Total Cartilage Replacement (TCR)™

Intervention Type DEVICE

Interventions

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GRADION™ Hip Total Cartilage Replacement (TCR)™

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No