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P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems

NCT00208286 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-06-20

No results posted yet for this study

Summary

This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

PFC Sigma Fixed Bearing

PFC Sigma Fixed Bearing system for use in total knee arthroplasty

DEVICE

PFC Sigma Mobile Bearing

PFC Sigma Mobile Bearing system for use in total knee arthroplasty

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2006-10-31
Completion
2015-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208286 on ClinicalTrials.gov