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

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ClinicalTrials.gov Identifier: NCT00487565
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : March 23, 2012
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Juvenile Arthritis Device: Total knee arthroplasty Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
LCS Complete Posterior Stabilized knee implant
Total knee arthroplasty with a posterior stabilized implant
Device: Total knee arthroplasty
Total knee arthroplasty using a posterior stabilized implant
Other Name: LCS® Complete Posterior Stabilized Mobile-bearing Knee




Primary Outcome Measures :
  1. Knee Active Flexion [ Time Frame: 12 month ]
    Active flexion is measured by how much a patient can bend their knee on their own, without assistance.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487565


Locations
United States, Colorado
Colorado Joint Replacement
Denver, Colorado, United States, 80210
United States, Pennsylvania
Joint Reconstruction Center
Pittsburgh, Pennsylvania, United States, 15260
United States, Virginia
Jordan-Young Institute
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy O'Dell, EMT, CCRA, CCRC DePuy

Additional Information:
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00487565     History of Changes
Other Study ID Numbers: 06005
LCS:PS
First Posted: June 18, 2007    Key Record Dates
Results First Posted: March 23, 2012
Last Update Posted: August 14, 2013
Last Verified: August 2013

Keywords provided by DePuy Orthopaedics:
Total knee replacement
Total knee arthroplasty
Osteoarthritis
Rheumatoid or other inflammatory arthritis
Post-traumatic or juvenile arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases