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

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ClinicalTrials.gov Identifier: NCT00289081
Recruitment Status : Terminated (Business reasons)
First Posted : February 9, 2006
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Arthritis, Rheumatoid Avascular Necrosis of Bone Post-traumatic Arthritis Rheumatoid Arthritis Device: Total Knee Replacement Device: Total knee replacement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Rotating Platform Cruciate Retaining Knee implant
Device: Total Knee Replacement
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.




Primary Outcome Measures :
  1. Knee Society scores [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ]

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


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

Inclusion Criteria:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Avascular necrosis (AVN) of bone
  • Other inflammatory arthritis
  • Post-traumatic arthritis
  • Juvenile rheumatoid arthritis

Exclusion Criteria:

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders
  • 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
  • Severe diabetes mellitus
  • Skeletal immaturity

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): NCT00289081


Locations
United States, California
La Jolla, California, United States, 92037
United States, Florida
West Coast Orthopaedic Specialists
Crystal River, Florida, United States, 34429
Melbourne, Florida, United States, 32901
United States, Ohio
Cleveland Heights, Ohio, United States, 44118
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy L O'Dell, EMT, CCRA DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289081     History of Changes
Other Study ID Numbers: SRP-1
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by DePuy Orthopaedics:
Total Knee Replacement

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