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

N/ATerminatedNCT01982266

Biomimedica, Inc4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Joint Disease of the Hip

Interventions

GRADION™ Hip Total Cartilage Replacement (TCR)™DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rijnstate Arnhem

Arnhem, Netherlands

Outcomes

Primary Outcomes

Adverse events

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.