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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982266

Enrollment

Registered

2013-11-13

Start date

2013-11-30

Completion date

2014-08-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Joint Disease of the Hip

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.

Interventions

DEVICEGRADION™ Hip Total Cartilage Replacement (TCR)™

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	6 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026