Back to resultsClinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total knee replacement, Total knee arthroplasty, Osteoarthritis, Rheumatoid or other inflammatory arthritis, Post-traumatic or juvenile arthritis
Eligibility Criteria
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.
Sites / Locations
- Colorado Joint Replacement
- Joint Reconstruction Center
- Jordan-Young Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LCS Complete Posterior Stabilized knee implant
Arm Description
Total knee arthroplasty with a posterior stabilized implant
Outcomes
Primary Outcome Measures
Knee Active Flexion
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487565
Brief Title
Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Official Title
LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Arthritis
Keywords
Total knee replacement, Total knee arthroplasty, Osteoarthritis, Rheumatoid or other inflammatory arthritis, Post-traumatic or juvenile arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LCS Complete Posterior Stabilized knee implant
Arm Type
Other
Arm Description
Total knee arthroplasty with a posterior stabilized implant
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty
Other Intervention Name(s)
LCS® Complete Posterior Stabilized Mobile-bearing Knee
Intervention Description
Total knee arthroplasty using a posterior stabilized implant
Primary Outcome Measure Information:
Title
Knee Active Flexion
Description
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy O'Dell, EMT, CCRA, CCRC
Organizational Affiliation
DePuy
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Joint Reconstruction Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Jordan-Young Institute
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.arthritis.org
Description
Related Info
Learn more about this trial
Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
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