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Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

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ClinicalTrials.gov Identifier: NCT00289094
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : December 10, 2010
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Juvenile Rheumatoid Arthritis Avascular Necrosis of Bone Device: Total Knee Replacement Device: Total knee replacement

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
Study Start Date : March 2001
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System
Device: Total Knee Replacement
Rotating Platform (RP) Cruciate Retaining Knee System
Other Name: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
Active Comparator: 2
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Device: Total knee replacement
Fixed Cruciate Retaining Knee System
Other Name: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Complications/Revisions [ Time Frame: On-going to end of study. ]
  2. Medical Imaging [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]
  3. SF-12 Patient Outcomes [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289094


Locations
United States, Montana
Billings, Montana, United States, 59101
United States, Washington
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy L O'Dell, EMT, CCRA, CCRC DePuy Orthopaedics
More Information

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289094     History of Changes
Other Study ID Numbers: SRP-2
First Posted: February 9, 2006    Key Record Dates
Results First Posted: December 10, 2010
Last Update Posted: August 14, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Arthritis, Juvenile
Osteonecrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases