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
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Device: P.F.C. Sigma Total Knee System
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: Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 731
Study Start Date: October 2000
Study Completion Date: June 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sigma Fixed Bearing Total Knee System

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00734110

Locations
United Kingdom
Princess Alexandra Hospital NHS Trust
Harlow, Essex, United Kingdom, CM20 1QX
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Paul W Allen, FRCS Princess Alexandra Hospital, Essex
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00734110     History of Changes
Other Study ID Numbers: CT 99/24
Study First Received: August 11, 2008
Last Updated: May 29, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014