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

Osteoarthritis Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00733681
• Other study ID #: CT 02/14
• Status: Terminated
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: January 21, 2015
• Start date: March 2004
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 181
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• PFC Sigma RP TC3 Revision knee system
Orthopaedic implant system for revision total knee replacement

Locations

Country	Name	City	State
France	CHU	Amiens
Germany	Orthopaedische Universitaetsklinik	Heidelberg
Germany	Asklepios Klinik	Lindenlohe
Switzerland	Geneva University Hospital	Geneva
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Princess Alexandra Hospital NHS Site	Harlow	Essex
United Kingdom	Leicester General Infirmary	Leicester
United Kingdom	City Hospital	Nottingham	Nottinghamshire
United Kingdom	Robert Jones & Agnes Hunt Orthopaedic Hospital	Oswestry

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

France,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival		5 years	No
Secondary	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	Yes