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A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

NCT00761410 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2016-06-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.

Conditions

Interventions

DEVICE

P.F.C. Sigma RP-F Total Knee Replacement

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2010-02-28
Completion
2015-05-31

Countries

  • India
  • Japan
  • New Zealand
  • Singapore
  • South Korea
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00761410 on ClinicalTrials.gov