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Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System

NCT00734110 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 723

Last updated 2025-10-10

No results posted yet for this study

Summary

The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.

In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.

Conditions

Interventions

DEVICE

P.F.C. Sigma Total Knee System

An orthopaedic implant for total knee replacement

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-01
Primary Completion
2009-04-01
Completion
2010-06-01

Countries

  • 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 NCT00734110 on ClinicalTrials.gov