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

• Sponsor: DePuy International (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00734019
• Collaborator: (none)
• Enrollment: 650
• Locations: 5
• Actual Duration (Months): 173.2
• Patients Per Site: 130
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

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 Design

• Study Type: Observational
• Actual Enrollment: 650 participants
• 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: Oct 1, 2005
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Mar 9, 2020

Arms and Interventions

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

Outcome Measures

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. [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. [3 month, 1,3, 5 and 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asklepios Klinic/ Lindenlohe Orthopeadic Hospital	Schwandorf	Deutschland	Germany
2	Hospital S Antonìo Of Padova	Padova		Italy
3	Princess Alexandra Hospital	Harlow	Essex	United Kingdom	CM20 1QX
4	Queen Margaret Hospital	Dunfermline	Fife	United Kingdom	KY12 0SU
5	Arrowe Park Hospital	The Wirral	Merseyside	United Kingdom	CH49 5PE

Sponsors and Collaborators

• DePuy International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy International
• ClinicalTrials.gov Identifier: NCT00734019
• Other Study ID Numbers: CT 04/16
• First Posted: Aug 13, 2008
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by DePuy International: Arthroplasty, Replacement, Knee, TKR, PFC Sigma
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Dec 1, 2021