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A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee

This study has been terminated.
(The study was terminated at 2 years as investigators were unable to continue participation in the study.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733486
First received: August 11, 2008
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years.

The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.


Condition Intervention Phase
Osteoarthritis
 Device: L.C.S. APG Knee Anterior Posterior Glide knee
 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: A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (AP Glide) Mobile Bearing Knee System in Primary Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline to each post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score. [ Time Frame: 3 month, 1, 3, 5 and 7 years post operatively ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: August 2005
Estimated Study Completion Date: January 2015
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement
 Device: L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement

Detailed Description:

Clinical and patient outcome secondary endpoints:

changes in baseline to each post operative assessment in

  1. Clinical outcome (stability, pain, range of motion and function) using the American Knee Society score
  2. Incidence of anterior knee pain and patellar function using the patellar score
  3. patient derived outcome in terms of joint specific quality of life as determined by the oxford knee score patient derived outcome in terms of general quality of life as determined by the Sf-12

Radiographic secondary endpoints:

Assessment of component alignment, positioning and radiolucencies at all post operative time points.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, aged between 45 and 85 years inclusive.
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  • Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
  • Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
  • Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  • Revision of an existing knee implant (including unicompartmental implants).
  • Female subjects who are pregnant.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
  • Subjects who are currently involved in any personal injury litigation claims.
  • Subjects involved in personal Medical-Legal claims.
  • Subjects with a known history of poor compliance to medical treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733486

Locations
Korea, Republic of
Dong-A University medical centre
Pusan, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Severance Hospital, Yongsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Jae-Doo Doo, FRCS Ewha Womans University
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733486     History of Changes
Other Study ID Numbers: CT 02/41
Study First Received: August 11, 2008
Last Updated: May 29, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 13, 2013