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

DePuy Orthopaedics210 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Juvenile Arthritis

Interventions

Total knee arthroplastyDEVICE

Total knee arthroplasty using a posterior stabilized implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Colorado Joint Replacement

Denver, Colorado, United States

Joint Reconstruction Center

Pittsburgh, Pennsylvania, United States

Jordan-Young Institute

Virginia Beach, Virginia, United States

Outcomes

Primary Outcomes

Knee Active Flexion

Active flexion is measured by how much a patient can bend their knee on their own, without assistance.

Time frame: 12 month

Data from ClinicalTrials.gov

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