NCT00733681

Brief Summary

The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_4

Geographic Reach
4 countries

9 active sites

Status
terminated

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

March 1, 2004

Completed
4.4 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
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

9.9 years

First QC Date

August 11, 2008

Last Update Submit

January 21, 2015

Conditions

Osteoarthritis

Keywords

Arthroplasty, Replacement, KneeProsthesis FailureRevision surgery

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    5 years

Secondary Outcomes (1)

  • Clinical/functional outcome (Knee Society & Patellar Scores). Health-related QoL (WOMAC OA Index). Patient Satisfaction at 1 & 5 years (2 patient questions). Radiographic analysis (Knee Society guidelines). Annual implant survival to 15 years.

    6 months, 1, 2, 3, 5, 10 and 15 years

Study Arms (1)

PFC Sigma RP TC3 Revision Knee System

EXPERIMENTAL

Revision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing).

Device: PFC Sigma RP TC3 Revision knee system

Interventions

PFC Sigma RP TC3 Revision knee systemDEVICE

Orthopaedic implant system for revision total knee replacement

Also known as: Sigma RP TC3
PFC Sigma RP TC3 Revision Knee System

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects over the age of 21 years (and skeletally mature).
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  • Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
  • Subjects who require revision of any previous knee arthroplasty.
  • Subjects who, in the opinion of the Clinical Investigator, are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
  • Subjects who require revision of the femoral and/or tibial components. (Both components must be replaced as part of the study.)

You may not qualify if:

  • Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
  • Women who are pregnant.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last 60 days (excluding any primary knee replacement study).
  • Subjects who are currently involved in any injury litigation claims.
  • Subjects with global instability, deficient extensor mechanism or severe bone loss (eg. due to fracture or tumour resection).
  • Subjects who have had their contralateral knee replaced within the previous 6-month period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU

Amiens, France

Location

Orthopaedische Universitaetsklinik

Heidelberg, D-69118, Germany

Location

Asklepios Klinik

Lindenlohe, Germany

Location

Geneva University Hospital

Geneva, Switzerland

Location

Princess Alexandra Hospital NHS Site

Harlow, Essex, CM20 1QX, United Kingdom

Location

City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Leicester General Infirmary

Leicester, LE3 9QP, United Kingdom

Location

Robert Jones & Agnes Hunt Orthopaedic Hospital

Oswestry, WY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

OsteoarthritisProsthesis Failure

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter J James, FRCS

    City Hospital, Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

March 1, 2004

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

DE(2)FR(1)CH(1)GB(5)