search
Back to results

The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty (TC3)

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PFC Sigma RP TC3 Revision knee system
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee, Prosthesis Failure, Revision surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHU
  • Orthopaedische Universitaetsklinik
  • Asklepios Klinik
  • Geneva University Hospital
  • Princess Alexandra Hospital NHS Site
  • City Hospital
  • Western Infirmary
  • Leicester General Infirmary
  • Robert Jones & Agnes Hunt Orthopaedic Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PFC Sigma RP TC3 Revision Knee System

Arm Description

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

Outcomes

Primary Outcome Measures

Implant survival

Secondary Outcome Measures

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.

Full Information

First Posted
August 11, 2008
Last Updated
January 21, 2015
Sponsor
DePuy International
search

1. Study Identification

Unique Protocol Identification Number
NCT00733681
Brief Title
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
Acronym
TC3
Official Title
A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Subjects were no longer able to remain compliant with follow-up intervals
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthroplasty, Replacement, Knee, Prosthesis Failure, Revision surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFC Sigma RP TC3 Revision Knee System
Arm Type
Experimental
Arm Description
Revision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing).
Intervention Type
Device
Intervention Name(s)
PFC Sigma RP TC3 Revision knee system
Other Intervention Name(s)
Sigma RP TC3
Intervention Description
Orthopaedic implant system for revision total knee replacement
Primary Outcome Measure Information:
Title
Implant survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
6 months, 1, 2, 3, 5, 10 and 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J James, FRCS
Organizational Affiliation
City Hospital, Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Amiens
Country
France
Facility Name
Orthopaedische Universitaetsklinik
City
Heidelberg
ZIP/Postal Code
D-69118
Country
Germany
Facility Name
Asklepios Klinik
City
Lindenlohe
Country
Germany
Facility Name
Geneva University Hospital
City
Geneva
Country
Switzerland
Facility Name
Princess Alexandra Hospital NHS Site
City
Harlow
State/Province
Essex
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Leicester General Infirmary
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Robert Jones & Agnes Hunt Orthopaedic Hospital
City
Oswestry
ZIP/Postal Code
WY10 7AG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty

We'll reach out to this number within 24 hrs