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

DePuy Synthes

Status and phase

Terminated

Phase 4

Conditions

Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00733486

CT 02/41

Details and patient eligibility

About

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.

Enrollment

233 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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.