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

This study has been terminated.
(The study achieved the stated objective to record pre & post operative outcomes at a minimum 5 years.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00734110
First received: August 11, 2008
Last updated: May 29, 2013
Last verified: May 2013

August 11, 2008
May 29, 2013
October 2000
March 2009   (final data collection date for primary outcome measure)
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734110 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
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.

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.

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 Total Knee System
An orthopaedic implant for total knee replacement
Other Name: Sigma Fixed Bearing Total Knee System
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.
Intervention: Device: P.F.C. Sigma Total Knee System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
731
June 2010
March 2009   (final data collection date for primary outcome measure)

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 contrainidcations for the use of the P.F.C. ® S Knee System as listed in the package insert.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00734110
CT 99/24
No
DePuy International
DePuy International
Not Provided
Principal Investigator: Paul W Allen, FRCS Princess Alexandra Hospital, Essex
DePuy International
May 2013

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