Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
2 other identifiers
interventional
210
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 23, 2012
CompletedAugust 14, 2013
August 1, 2013
4.4 years
June 14, 2007
February 21, 2012
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Active Flexion
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
12 month
Study Arms (1)
LCS Complete Posterior Stabilized knee implant
OTHERTotal knee arthroplasty with a posterior stabilized implant
Interventions
Total knee arthroplasty using a posterior stabilized implant
Eligibility Criteria
You may qualify if:
- M/F
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Colorado Joint Replacement
Denver, Colorado, 80210, United States
Joint Reconstruction Center
Pittsburgh, Pennsylvania, 15260, United States
Jordan-Young Institute
Virginia Beach, Virginia, 23462, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tammy O'Dell
- Organization
- DePuy Orthopaedics, Inc.
Study Officials
- STUDY DIRECTOR
Tammy O'Dell, EMT, CCRA, CCRC
DePuy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 18, 2007
Study Start
September 1, 2006
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 14, 2013
Results First Posted
March 23, 2012
Record last verified: 2013-08