Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System

DePuy Synthes

Status and phase

Completed

Phase 4

Conditions

Arthroplasty, Replacement, Knee

Treatments

Device: L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00733915

CT 01/13

Details and patient eligibility

About

The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.

Full description

The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.

Enrollment

241 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a mobile bearing knee system (LCS Complete).
Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, 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.
Subjects with a known history of poor compliance to medical treatment.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Subjects involved in Medical-Legal claims.
Subjects who have participated in a clinical study with an investigational product in the last month.
Subjects who are currently involved in any injury litigation claims.
Revision of an existing knee implant.