NCT00734019

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

13.8 years

First QC Date

August 11, 2008

Last Update Submit

November 29, 2021

Conditions

Knee Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, TKR, PFC Sigma

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

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

Interventions

P.F.C. Sigma KneeDEVICE

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

P.F.C. Sigma Knee System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Asklepios Klinic/ Lindenlohe Orthopeadic Hospital

Schwandorf in Bayern, Deutschland, Germany

Location

Hospital S Antonìo Of Padova

Padua, Italy

Location

Princess Alexandra Hospital

Harlow, Essex, CM20 1QX, United Kingdom

Location

Queen Margaret Hospital

Dunfermline, Fife, KY12 0SU, United Kingdom

Location

Arrowe Park Hospital

The Wirral, Merseyside, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

October 1, 2005

Primary Completion

July 3, 2019

Study Completion

March 9, 2020

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations

DE(1)IT(1)GB(3)