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

DePuy Synthes

Status: Terminated

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289081

SRP-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 399 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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399 participants in 2 patient groups

1

Active Comparator group

Description:

Rotating Platform Cruciate Retaining Knee implant

Treatment:

Device: Total Knee Replacement

2

Active Comparator group

Description:

Rotating Platform Cruciate Substituting Knee implant.

Treatment:

Device: Total knee replacement