TerminatedPhase 4

A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement

Stopped: Study terminated early due to business reasons

Italy, United Kingdom163 participantsStarted 2004-04

Plain-language summary

The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
✕. Subjects with an occupational exposure to cobalt or chromium.
✕. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
✕. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
✕. Subjects who are undergoing a simultaneous bilateral total hip replacement.

What they're measuring

Kaplan-Meier survivorship calculated at the 5 year time point.

Timeframe: 5 years

Trial details

NCT IDNCT00208364

SponsorDePuy International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Rheumatoid Arthritis trials