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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Locations

International

Study Type

Observational

Intervention

P.F.C. Sigma Knee

About this trial

This is an observational trial for Knee Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee, TKR, PFC Sigma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asklepios Klinic/ Lindenlohe Orthopeadic Hospital
Hospital S Antonìo Of Padova
Princess Alexandra Hospital
Queen Margaret Hospital
Arrowe Park Hospital

Arms of the Study

Arm 1

Arm Type

Arm Label

P.F.C. Sigma Knee System

Arm Description

Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Outcomes

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.

Secondary Outcome Measures

Changes from pre-operative assessment Clinical outcome and patient-derived outcome in terms of joint-specific quality of life.

Full Information

NCT ID

NCT00734019

First Posted

August 11, 2008

Last Updated

November 29, 2021

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00734019

Brief Title

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

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.

Study Type

Observational

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2005 (Actual)

Primary Completion Date

July 3, 2019 (Actual)

Study Completion Date

March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, TKR, PFC Sigma

7. Study Design

Enrollment

650 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P.F.C. Sigma Knee System

Arm Description

Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Intervention Type

Device

Intervention Name(s)

P.F.C. Sigma Knee

Intervention Description

Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Asklepios Klinic/ Lindenlohe Orthopeadic Hospital

City

Schwandorf

State/Province

Deutschland

Country

Germany

Facility Name

Hospital S Antonìo Of Padova

City

Padova

Country

Italy

Facility Name

Princess Alexandra Hospital

City

Harlow

State/Province

Essex

ZIP/Postal Code

CM20 1QX

Country

United Kingdom

Facility Name

Queen Margaret Hospital

City

Dunfermline

State/Province

Fife

ZIP/Postal Code

KY12 0SU

Country

United Kingdom

Facility Name

Arrowe Park Hospital

City

The Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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