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

This study has been completed.
Information provided by (Responsible Party):
DePuy Orthopaedics Identifier:
First received: June 14, 2007
Last updated: August 6, 2013
Last verified: August 2013
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 Intervention
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Juvenile Arthritis Device: Total knee arthroplasty

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • 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.

Enrollment: 210
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00487565

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
Study Director: Tammy O'Dell, EMT, CCRA, CCRC DePuy
  More Information

Additional Information:
Responsible Party: DePuy Orthopaedics Identifier: NCT00487565     History of Changes
Other Study ID Numbers: 06005
Study First Received: June 14, 2007
Results First Received: February 21, 2012
Last Updated: August 6, 2013

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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 18, 2017