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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00487565
First received: June 14, 2007
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Phase
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Arthritis
 Device: Total knee arthroplasty
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee Active Flexion [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00487565     History of Changes
Other Study ID Numbers: 06005, LCS:PS
Study First Received: June 14, 2007
Results First Received: February 21, 2012
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

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
Arthritis, Rheumatoid
Osteoarthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013