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

NCT ID: NCT00733486

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L.C.S. APG Knee Anterior Posterior Glide knee

Orthopaedic implant for primary knee replacement

Group Type: OTHER

L.C.S. APG Knee Anterior Posterior Glide knee

Intervention Type: DEVICE

Orthopaedic implant for primary knee replacement

Interventions

L.C.S. APG Knee Anterior Posterior Glide knee

Orthopaedic implant for primary knee replacement

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dong-A University medical centre

Pusan, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Severance Hospital, Yongsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CT 02/41

Identifier Type: -

Identifier Source: org_study_id