- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289094
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
August 16, 2022 updated by: DePuy Orthopaedics
Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement.
Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants.
This will be done by obtaining a series of primary total knee replacements.
Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Montana
-
Billings, Montana, United States, 59101
-
-
Washington
-
Vancouver, Washington, United States, 98664
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Osteoarthritis
- Rheumatoid Arthritis
- Other inflammatory arthritis
- Avascular necrosis of bone
Exclusion Criteria:
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System
|
Rotating Platform (RP) Cruciate Retaining Knee System
Other Names:
|
Active Comparator: 2
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
|
Fixed Cruciate Retaining Knee System
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Society Scores
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points.
One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment.
The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids.
For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
|
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medical Imaging
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
SF-12 Patient Outcomes
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
|
Complications/Revisions
Time Frame: On-going to end of study.
|
On-going to end of study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tammy L O'Dell, EMT, CCRA, CCRC, DePuy Orthopaedics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2001
Primary Completion (Actual)
December 26, 2007
Study Completion (Actual)
December 26, 2007
Study Registration Dates
First Submitted
February 7, 2006
First Submitted That Met QC Criteria
February 7, 2006
First Posted (Estimate)
February 9, 2006
Study Record Updates
Last Update Posted (Actual)
September 13, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRP-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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