The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 11, 2008
Last updated: October 8, 2012
Last verified: October 2012
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.
Device: PFC Sigma RP TC3 Revision knee system
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Implant survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 6 months, 1, 2, 3, 5, 10 and 15 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Experimental: PFC Sigma RP TC3 Revision Knee System
Revision knee surgery with the PFC Sigma RP TC3 Revision Knee System (mobile bearing).
Device: PFC Sigma RP TC3 Revision knee system
Orthopaedic implant system for revision total knee replacement
Other Name: Sigma RP TC3
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.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733681
|Amiens, France |
|Heidelberg, Germany, D-69118 |
|Lindenlohe, Germany |
|Geneva University Hospital
|Geneva, Switzerland |
|Princess Alexandra Hospital NHS Site
|Harlow, Essex, United Kingdom, CM20 1QX |
|Nottingham, Nottinghamshire, United Kingdom, NG5 1PB |
|Glasgow, United Kingdom, G11 6NT |
|Leicester General Infirmary
|Leicester, United Kingdom, LE3 9QP |
|Robert Jones & Agnes Hunt Orthopaedic Hospital
|Oswestry, United Kingdom, WY10 7AG |
||Peter J James, FRCS
||City Hospital, Nottingham
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 11, 2008
||October 8, 2012
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013