Clinical trial NCT00733681: The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee
Prosthesis Failure
Revision surgery
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 181
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Implant survival
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 6 months, 1, 2, 3, 5, 10 and 15 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Heidelberg
country: Germany
facility: Orthopaedische Universitaetsklinik
city: Lindenlohe
country: Germany
facility: Asklepios Klinik
city: Geneva
country: Switzerland
facility: Geneva University Hospital
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital NHS Site
state: Essex
city: Nottingham
country: United Kingdom
facility: City Hospital
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: Leicester
country: United Kingdom
facility: Leicester General Infirmary
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
Study officials:
affiliation: City Hospital, Nottingham
name: Peter J James, FRCS
role: PRINCIPAL_INVESTIGATOR
References: