The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty (TC3)

January 21, 2015 updated by: DePuy International

A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.

The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU
  • Germany
      • Heidelberg, Germany, D-69118
        • Orthopaedische Universitaetsklinik
      • Lindenlohe, Germany
        • Asklepios Klinik
  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Western Infirmary
      • Leicester, United Kingdom, LE3 9QP
        • Leicester General Infirmary
      • Oswestry, United Kingdom, WY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital
    • Essex
      • Harlow, Essex, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital NHS Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects over the age of 21 years (and skeletally mature).
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  • Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
  • Subjects who require revision of any previous knee arthroplasty.
  • Subjects who, in the opinion of the Clinical Investigator, are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
  • Subjects who require revision of the femoral and/or tibial components. (Both components must be replaced as part of the study.)

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
  • Women who are pregnant.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last 60 days (excluding any primary knee replacement study).
  • Subjects who are currently involved in any injury litigation claims.
  • Subjects with global instability, deficient extensor mechanism or severe bone loss (eg. due to fracture or tumour resection).
  • Subjects who have had their contralateral knee replaced within the previous 6-month period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PFC Sigma RP TC3 Revision Knee System
Revision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing).
Device: PFC Sigma RP TC3 Revision knee system
Orthopaedic implant system for revision total knee replacement
Other Names:
  • Sigma RP TC3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Implant survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical/functional outcome (Knee Society & Patellar Scores). Health-related QoL (WOMAC OA Index). Patient Satisfaction at 1 & 5 years (2 patient questions). Radiographic analysis (Knee Society guidelines). Annual implant survival to 15 years.
Time Frame: 6 months, 1, 2, 3, 5, 10 and 15 years
6 months, 1, 2, 3, 5, 10 and 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy International

Investigators

  • Principal Investigator: Peter J James, FRCS, City Hospital, Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 02/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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