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NCT Number: NCT00487565

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

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Juvenile Arthritis Musculoskeletal Diseases Post-traumatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Joint Replacement, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty

Device

Total knee arthroplasty using a posterior stabilized implant

Other names: LCS® Complete Posterior Stabilized Mobile-bearing Knee

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jun 18, 2007
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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