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Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

This study has been terminated.
(Business reasons)
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289081
First received: February 7, 2006
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.


Condition Intervention Phase
Osteoarthritis
Arthritis, Rheumatoid
Avascular Necrosis of Bone
 Device: Total Knee Arthroplasty
Device: Total knee replacement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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: 399
Study Start Date: October 2000
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Rotating Platform Cruciate Retaining Knee implant
 Device: Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Retaining Knee implant
Other Name: P.F.C.® Sigma™ RP Cruciate Retaining Knee implant
Active Comparator: 2
Rotating Platform Cruciate Substituting Knee implant.
 Device: Total knee replacement
Rotating Platform (RP) Cruciate Substituting Knee implant.
Other Name: P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.

Detailed Description:

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be 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
  • Avascular necrosis (AVN) of bone
  • Other inflammatory arthritis

Exclusion Criteria:

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289081

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: NCT00289081     History of Changes
Other Study ID Numbers: SRP-1
Study First Received: February 7, 2006
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Total Knee Replacement

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

ClinicalTrials.gov processed this record on May 16, 2013