Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733681
First received: August 11, 2008
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: PFC Sigma RP TC3 Revision knee system
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by DePuy International:

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 ]

Enrollment: 181
Study Start Date: March 2004
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733681

Locations
France
CHU
Amiens, France
Germany
Orthopaedische Universitaetsklinik
Heidelberg, Germany, D-69118
Asklepios Klinik
Lindenlohe, Germany
Switzerland
Geneva University Hospital
Geneva, Switzerland
United Kingdom
Princess Alexandra Hospital NHS Site
Harlow, Essex, United Kingdom, CM20 1QX
City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Leicester General Infirmary
Leicester, United Kingdom, LE3 9QP
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, United Kingdom, WY10 7AG
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Peter J James, FRCS City Hospital, Nottingham
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733681     History of Changes
Other Study ID Numbers: CT 02/14
Study First Received: August 11, 2008
Last Updated: October 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee
Prosthesis Failure
Revision surgery

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 23, 2014