Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

DePuy Synthes

Status: Completed

Conditions: Osteoarthritis; Juvenile Arthritis; Post-traumatic Arthritis; Rheumatoid Arthritis

Treatments: Device: Total knee arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT00487565

LCS:PS

06005

Details and patient eligibility

About

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Full description

Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Enrollment: 210 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• M/F
• 18-80
• Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
• Skeletally mature, sufficient bone stock to seat and support prosthesis
• Willing/able return for follow-up.
• Subject is willing and able to provide informed patient consent for participation in the study

Exclusion criteria

• History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
• Communicable diseases that may limit follow-up
• Medical-legal or workers compensation claims.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

LCS Complete Posterior Stabilized knee implant

Other group

Description:

Total knee arthroplasty with a posterior stabilized implant

Treatment:

Device: Total knee arthroplasty