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

June 5, 2015 updated by: DePuy International

Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.

Study Type

Interventional

Enrollment (Actual)

723

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

  • United Kingdom
    • Essex
      • Harlow, Essex, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital NHS Trust

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have given voluntary written informed consent to participate in this study.
  • Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
  • Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
  • Male or female patients who are skeletally mature and for whom an appropriate size of device is available.

Exclusion Criteria:

  • Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
  • Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
  • Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
  • Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
  • Patients having non-contained defects in the tibia or femur necessitating bone graft.
  • Patients with psychosocial disorders that would limit rehabilitation or follow-up.
  • Subjects with a known history of poor compliance to medical treatment.
  • Subjects who are known drug or alcohol abusers.
  • Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P.F.C. Sigma Total Knee Replacement System
Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.
Device: P.F.C. Sigma Total Knee System
An orthopaedic implant for total knee replacement
Other Names:
  • Sigma Fixed Bearing Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Time Frame: 6 weeks, 1, 2, 5 years
6 weeks, 1, 2, 5 years

Collaborators and Investigators

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

Sponsor

DePuy International

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

July 1, 2000

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2010

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)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 99/24

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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