Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734019
Recruitment Status : Active, not recruiting
First Posted : August 13, 2008
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
DePuy International

Brief Summary:
The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: P.F.C. Sigma Knee Phase 4

Detailed Description:
The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-Years. The secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the P.F.C. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. These outcomes will include Radiographic assessment, American Knee Society Score, Oxford Knee Score and SF-12.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-comparative, Multicentre, Multinational Study to Determine the Survivorship of the P.F.C. Fixed Bearing Knee System Using a Moderately Cross-linked Polyethylene Insert and a Cobalt Chrome Tibial Tray.
Actual Study Start Date : October 1, 2005
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
P.F.C. Sigma Knee System
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert
Device: P.F.C. Sigma Knee
Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Primary Outcome Measures :
  1. The primary endpoint is a survivorship analysis of the P.F.C. fixed bearing knee system with a cobalt chrome tibial tray and moderately cross linked polyethylene insert at the five-year time point. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life. [ Time Frame: 3 month, 1,3, 5 and 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who have given voluntary written informed consent to participate in this study
  • Subjects 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.
  • Subjects 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 scheduled post-operative follow ups.
  • Male or Female subjects who are skeletally mature and for whom an appropriate size of device is available
  • The following subjects are not considered eligible and must not be recruited to the investigation

Exclusion Criteria:

  • Subjects scheduled for revision total knee arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
  • Subjects aged over 80 Years
  • Subjects experiencing any condition that may, in the opinion of the investigator, interfere with the total knee replacements survival or outcome (e.g. Pagets disease, Charcots disease, severe osteoporosis etc).
  • Subjects 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)
  • Subjects who are currently participating in any other clinical investigation of a device or pharmaceutical.
  • Subjects having non-contained defects in the tibia or femur necessitating bone graft.
  • Subjects with psychosocial disorders that would limit rehabilitation
  • 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 fixed bearing knee system as listed in the package insert.
  • Women who are pregnant
  • Subjects who are currently involved in any injury litigation claims

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00734019

Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
Schwandorf, Deutschland, Germany
Hospital S Antonìo Of Padova
Padova, Italy
United Kingdom
Princess Alexandra Hospital
Harlow, Essex, United Kingdom, CM20 1QX
Queen Margaret Hospital
Dunfermline, Fife, United Kingdom, KY12 0SU
Arrowe Park Hospital
The Wirral, Merseyside, United Kingdom, CH49 5PE
Sponsors and Collaborators
DePuy International

Responsible Party: DePuy International Identifier: NCT00734019     History of Changes
Other Study ID Numbers: CT 04/16
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee, TKR, PFC Sigma

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs