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Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289107
First received: February 7, 2006
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.


Condition Intervention Phase
Total Knee Replacement
 Device: Total Knee Arthroplasty
Device: Total knee replacement
 Phase 4

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 P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee Society Score [ 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 [ Time Frame: On-going to end of study ] [ Designated as safety issue: Yes ]
  • 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: 149
Study Start Date: May 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 Cruciate Substituting Knee System
 Device: Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
Other Name: P.F.C.® Sigma™ RP Cruciate Substituting Knee System
Active Comparator: 2
P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
 Device: Total knee replacement
Fixed Cruciate Substituting Knee System
Other Name: P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Detailed Description:

The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting 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 (AVN) of bone

Exclusion Criteria:

  • History of recent/active joint sepsis.
  • Charcot neuropathy.
  • Psycho-social disorders that would limit rehabilitation.
  • Greater than 75 years of age at the time of surgery.
  • Prior ipsilateral knee arthroplasty.
  • Metabolic disorders of calcified tissues, such as Paget's disease.
  • Severe diabetes mellitus.
  • Joint replacement due to autoimmune disorders.
  • Skeletal immaturity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289107

Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy L O'Dell, EMT, CCRA DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289107     History of Changes
Other Study ID Numbers: SRP-3
Study First Received: February 7, 2006
Results First Received: September 29, 2010
Last Updated: September 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Total Knee Replacement
Knee Prosthesis

ClinicalTrials.gov processed this record on May 16, 2013