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

Not Applicable

Completed

• Conditions: Juvenile Arthritis; Osteoarthritis; Post-traumatic Arthritis; Rheumatoid Arthritis
• Interventions: Device: Total knee arthroplasty

• Registration Number: NCT00487565
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-15
• Study First Posted: 2007-06-18
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-21
• Results First Submitted QC: 2012-02-21
• Results First Posted: 2012-03-23
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCS Complete Posterior Stabilized knee implant	Total knee arthroplasty	Total knee arthroplasty with a posterior stabilized implant

Primary Outcome Measures

Name	Time	Method
Knee Active Flexion	12 month	Active flexion is measured by how much a patient can bend their knee on their own, without assistance.

Trial Locations

Locations (3)

Joint Reconstruction Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States

Jordan-Young Institute; 🇺🇸 Virginia Beach, Virginia, United States