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: July 31, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Device: P.F.C. Sigma Knee
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • 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: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: October 2005
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734019

Locations
Germany
Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
Schwandorf, Deutschland, Germany
Italy
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
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00734019     History of Changes
Other Study ID Numbers: CT 04/16
Study First Received: August 11, 2008
Last Updated: July 31, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on October 20, 2014