Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

NCT ID: NCT00289107

Last Updated: 2023-05-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-01

Study Completion Date

2007-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis Rheumatoid Arthritis Other Inflammatory Arthritis Post-Traumatic Arthritis Juvenile Rheumatoid Arthritis Avascular Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type DEVICE

Rotating Platform (RP) Cruciate Substituting Knee System

2

P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Group Type ACTIVE_COMPARATOR

Total knee replacement

Intervention Type DEVICE

Fixed Cruciate Substituting Knee System

Interventions

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Total Knee Arthroplasty

Rotating Platform (RP) Cruciate Substituting Knee System

Intervention Type DEVICE

Total knee replacement

Fixed Cruciate Substituting Knee System

Intervention Type DEVICE

Other Intervention Names

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P.F.C.® Sigma™ RP Cruciate Substituting Knee System P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis
* Rheumatoid arthritis
* Other inflammatory arthritis
* Avascular necrosis (AVN) of bone
* Post-Traumatic Arthritis
* Juvenile Rheumatoid Arthritis

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
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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Greensboro, North Carolina, United States

Site Status

Austin, Texas, United States

Site Status

Lakewood, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SRP-3

Identifier Type: -

Identifier Source: org_study_id

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