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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):
DePuy Orthopaedics

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 9, 2006
Results First Submitted Date September 29, 2010
Results First Posted Date December 10, 2010
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE March 2001
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
Knee Society Scores
Change History Complete list of historical versions of study NCT00289094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
  • Complications/Revisions [ Time Frame: On-going to end of study. ]
  • Medical Imaging [ Time Frame: 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • Complications/Revisions,
  • Radiographic findings,
  • SF-12 Patient Outcomes
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Official Title  ICMJE Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic Arthritis
  • Juvenile Rheumatoid Arthritis
  • Avascular Necrosis of Bone
Intervention  ICMJE
  • Device: Total Knee Replacement
    Rotating Platform (RP) Cruciate Retaining Knee System
    Other Name: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
  • Device: Total knee replacement
    Fixed Cruciate Retaining Knee System
    Other Name: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Study Arms
  • Active Comparator: 1
    P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System
    Intervention: Device: Total Knee Replacement
  • Active Comparator: 2
    P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
    Intervention: Device: Total knee replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2010)
99
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00289094
Other Study ID Numbers  ICMJE SRP-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party DePuy Orthopaedics
Study Sponsor  ICMJE DePuy Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tammy L O'Dell, EMT, CCRA, CCRC DePuy Orthopaedics
PRS Account DePuy Orthopaedics
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP