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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733915
First received: August 11, 2008
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Device: L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate the survivorship and performance of the LCSâ 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 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: January 2002
Study Completion Date: December 2012
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Cohort of total knee replacements with LCS Complete knee implants
Device: L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
L.C.S. Complete mobile-bearing total knee system

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733915

Locations
Ireland
Musgrave Park Hospital
Belfast, Ireland, BT9 7JB
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: David Beverland, FRCS Musgrave Park Hospital
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733915     History of Changes
Other Study ID Numbers: CT 01/13
Study First Received: August 11, 2008
Last Updated: February 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Arthroplasty, knee, TKA, TKR, Duofix, Porocoat, LCS

ClinicalTrials.gov processed this record on August 28, 2014