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The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly

NCT00733928 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-03-30

No results posted yet for this study

Summary

The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.

Conditions

Interventions

DEVICE

PFC Sigma knee with all-poly tibial component

Orthopaedic implant for total knee replacement with an all-polyethylene tibial component

DEVICE

PFC Sigma knee with metal backed tibia

Orthopaedic implant for total knee replacement with a metal-backed tibial component

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-01
Primary Completion
2005-05-01
Completion
2015-03-01

Countries

  • United Kingdom

Study Locations

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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 NCT00733928 on ClinicalTrials.gov