Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289094
First received: February 7, 2006
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Rheumatoid Arthritis
Avascular Necrosis of Bone
Device: Total Knee Replacement
Device: Total knee replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee Society Scores [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]
    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:
  • Complications/Revisions [ Time Frame: On-going to end of study. ] [ Designated as safety issue: Yes ]
  • Medical Imaging [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: Yes ]
  • SF-12 Patient Outcomes [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: March 2001
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289094     History of Changes
Other Study ID Numbers: SRP-2
Study First Received: February 7, 2006
Results First Received: September 29, 2010
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014