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

NCT ID: NCT00289081

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rotating Platform Cruciate Retaining Knee implant

Group Type ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type DEVICE

Rotating Platform (RP) Cruciate Retaining Knee implant

2

Rotating Platform Cruciate Substituting Knee implant.

Group Type ACTIVE_COMPARATOR

Total knee replacement

Intervention Type DEVICE

Rotating Platform (RP) Cruciate Substituting Knee implant.

Interventions

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Total Knee Replacement

Rotating Platform (RP) Cruciate Retaining Knee implant

Intervention Type DEVICE

Total knee replacement

Rotating Platform (RP) Cruciate Substituting Knee implant.

Intervention Type DEVICE

Other Intervention Names

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P.F.C.® Sigma™ RP Cruciate Retaining Knee implant P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tammy L O'Dell, EMT, CCRA

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

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La Jolla, California, United States

Site Status

West Coast Orthopaedic Specialists

Crystal River, Florida, United States

Site Status

Melbourne, Florida, United States

Site Status

Cleveland Heights, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SRP-1

Identifier Type: -

Identifier Source: org_study_id

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