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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

August 11, 2008
May 29, 2013
August 2005
December 2010   (final data collection date for primary outcome measure)
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00733486 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Device: L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement
L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement
Intervention: Device: L.C.S. APG Knee Anterior Posterior Glide knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
233
January 2015
December 2010   (final data collection date for primary outcome measure)

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.
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00733486
CT 02/41
No
DePuy International
DePuy International
Not Provided
Principal Investigator: Jae-Doo Doo, FRCS Ewha Womans University Mokdong Hospital
DePuy International
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP