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TERMINATEDNANCT00289081

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

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 an...

Lead sponsor: DePuy Orthopaedics•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

DePuy Orthopaedics

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.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 13, 2014Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment399

Start dateFeb 2001

Last updatedMay 13, 2014

Condition

Osteoarthritis Arthritis, Rheumatoid Avascular Necrosis of Bone Post-traumatic Arthritis Rheumatoid Arthritis

Locations shown

La Jolla, California

West Coast Orthopaedic Specialists

Crystal River, Florida

Melbourne, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2014Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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