Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

DePuy Synthes

Status: Completed

Conditions: Other Inflammatory Arthritis; Osteoarthritis; Juvenile Rheumatoid Arthritis; Post-Traumatic Arthritis; Avascular Necrosis; Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289107

SRP-3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Device: Total Knee Arthroplasty

2

Active Comparator group

Description:

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

Treatment:

Device: Total knee replacement