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: August 6, 2013
Last verified: August 2013
  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
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Arthritis
Device: Total knee arthroplasty

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:


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.
  • 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 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:
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: August 6, 2013
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 July 22, 2014