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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00734019
First received: August 11, 2008
Last updated: April 7, 2014
Last verified: April 2014

August 11, 2008
April 7, 2014
October 2005
January 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734019 on ClinicalTrials.gov Archive Site
Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life. [ Time Frame: 3 month, 1,5 and 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray
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.

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

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
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
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.
Intervention: Device: P.F.C. Sigma Knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
January 2020
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United Kingdom
 
NCT00734019
CT 04/16
No
DePuy International
DePuy International
Not Provided
Principal Investigator: Ivan Brenkel, FRCS Queen Victoria Hospital, Fife
DePuy International
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP