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Clinical Trials/NCT01982266
NCT01982266TerminatedNot Applicable

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, Inc2 sites in 1 country4 target enrollmentStarted: November 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
4
Locations
2
Primary Endpoint
Adverse events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Adverse events

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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