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

NCT ID: NCT00733915

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-01
• Study Completion Date: 2014-10-01

Brief Summary

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

Detailed 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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

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

Study Groups

Single arm

Cohort of total knee replacements with LCS Complete knee implants

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

L.C.S. Complete mobile-bearing total knee system

Interventions

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

L.C.S. Complete mobile-bearing total knee system

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Musgrave Park Hospital

Belfast, , Ireland

Countries

Ireland

Other Identifiers

CT 01/13

Identifier Type: -

Identifier Source: org_study_id