Keramos Ceramic/Ceramic Total Hip System

Encore Medical, L.P.3 sites in 1 country342 target enrollmentNovember 2003

ConditionsRheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Encore Medical, L.P.
Enrollment: 342
Locations: 3
Primary Endpoint: Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

January 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Encore Medical, L.P.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis.
•Less than 70 on preoperative HHS score
•Primary total hip replacement
•Patient is likely to be available for evaluation for the duration of the study.

Exclusion Criteria

•Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor)
•Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement.
•Insufficient quality or quantity of bone resulting from conditions such as:
•Cancer, where radiation has destroyed the available bonestock
•Congenital dislocation
•Metabolic bone disease of the upper femur or pelvis
•Femoral osteotomy revision
•Girdlestone revision
•Active infection of the hip joint
•Old or remote infection