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PFC Sigma Fixed and Mobile Knee Study

NCT00208325 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2016-09-13

Study results available
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Summary

The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

P.F.C Sigma Fixed Bearing total knee system

Orthopaedic implant for total knee replacement

DEVICE

P.F.C Sigma RP Mobile Bearing knee system

Orthopaedic implant for total knee replacement

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
2000-05-31
Primary Completion
2009-01-31
Completion
2010-09-30

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 NCT00208325 on ClinicalTrials.gov