Back to resultsLong-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
Primary Purpose
Knee Osteoarthritis
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
P.F.C. Sigma Total Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP
Eligibility Criteria
Inclusion Criteria:
- Patients who have given voluntary written informed consent to participate in this study.
- Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
- Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
- Male or female patients who are skeletally mature and for whom an appropriate size of device is available.
Exclusion Criteria:
- Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
- Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
- Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
- Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
- Patients having non-contained defects in the tibia or femur necessitating bone graft.
- Patients with psychosocial disorders that would limit rehabilitation or follow-up.
- Subjects with a known history of poor compliance to medical treatment.
- Subjects who are known drug or alcohol abusers.
- Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.
Sites / Locations
- Princess Alexandra Hospital NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P.F.C. Sigma Total Knee Replacement System
Arm Description
Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.
Outcomes
Primary Outcome Measures
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Secondary Outcome Measures
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00734110
Brief Title
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
Official Title
Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
The study achieved the stated objective to record pre & post operative outcomes at a minimum 5 years.
Study Start Date
July 2000 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.
In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.
Detailed Description
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Arthroplasty, Replacement, Knee, P.F.C. Sigma RPF, Sigma RP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
723 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P.F.C. Sigma Total Knee Replacement System
Arm Type
Experimental
Arm Description
Primary total knee arthroplasty using the fixed bearing P.F.C. Sigma Total Knee Replacement System.
Intervention Type
Device
Intervention Name(s)
P.F.C. Sigma Total Knee System
Other Intervention Name(s)
Sigma Fixed Bearing Total Knee System
Intervention Description
An orthopaedic implant for total knee replacement
Primary Outcome Measure Information:
Title
To record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The secondary outcomes are any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported.
Time Frame
6 weeks, 1, 2, 5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have given voluntary written informed consent to participate in this study.
Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
Male or female patients who are skeletally mature and for whom an appropriate size of device is available.
Exclusion Criteria:
Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
Patients having non-contained defects in the tibia or femur necessitating bone graft.
Patients with psychosocial disorders that would limit rehabilitation or follow-up.
Subjects with a known history of poor compliance to medical treatment.
Subjects who are known drug or alcohol abusers.
Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.
Facility Information:
Facility Name
Princess Alexandra Hospital NHS Trust
City
Harlow
State/Province
Essex
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
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