Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

DePuy Synthes

Status: Completed

Conditions: Osteoarthritis; Juvenile Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis of Bone; Rheumatoid Arthritis

Treatments: Device: Total Knee Replacement; Device: Total knee replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289094

SRP-2

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Full description

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis
• Rheumatoid Arthritis
• Other inflammatory arthritis
• Avascular necrosis of bone

Exclusion criteria

• Prior ipsilateral TKA
• Metabolic disorders
• Joint replacement due to autoimmune disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

1

Active Comparator group

Description:

P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System

Treatment:

Device: Total Knee Replacement

2

Active Comparator group

Description:

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

Treatment:

Device: Total knee replacement