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

NCT00733915 | Completed Phase 4

• 1 other identifier: CT 01/13
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty, Replacement, Knee

Keywords

Arthroplasty, knee, TKA, TKR, Duofix, Porocoat, LCS

Outcome Measures

Primary Outcomes (1)

• To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment

  10 years

Secondary Outcomes (1)

• To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.

  Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years

Study Arms (1)

Single arm

EXPERIMENTAL

Cohort of total knee replacements with LCS Complete knee implants

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

Interventions

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

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

Single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Musgrave Park Hospital

Belfast, BT9 7JB, Ireland

Location

MeSH Terms

Conditions

Aagenaes syndrome

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: March 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2014
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

IE (1)