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Completed

NCT Number: NCT00733915

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Musgrave Park Hospital

Belfast, BT9 7JB, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

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

    Time frame: 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.

    Time frame: Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years

Sponsors and collaborators

Lead sponsor

DePuy International

Industry

Registry information

Official study title

A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.

Important dates

Study start
2002
Primary completion
2007
Study completion
2014
First posted
Aug 13, 2008
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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