NCT00733681TerminatedPhase 4
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.
DePuy International15 sites in 4 countries181 target enrollmentStarted: March 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 181
- Locations
- 15
- Primary Endpoint
- Implant survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Implant survival
Time Frame: 5 years
Secondary Outcomes
- 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)
Investigators
Study Sites (15)
Loading locations...
Similar Trials
Completed
Not Applicable
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral RectopexyRectal ProlapseNCT04130555Meccellis Biotech55
Recruiting
Not Applicable
Baker Gordon Syndrome Natural History StudyRare DiseasesAutism or Autistic TraitsDevelopment DelaySYT-SSX Fusion Protein ExpressionSleep DisorderEpilepsy, GeneralizedMotor DelayNCT06399952University of Missouri-Columbia50
Completed
Not Applicable
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)Atrial FibrillationNCT02168972Kardium Inc.60
Recruiting
Not Applicable
A prospective study to evaluate the clinical utility of liquid biopsy in cancer patients underwent tissue based comprehensive genome profiling.solid tumorJPRN-UMIN000041722ational cancer center130
Recruiting
Not Applicable
A prospective study to evaluate long-term clinical outcomes of the GTS cementless femoral stemJoint wear10023213OsteoarthritisNL-OMON55672Zimmer Biomet23