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A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low Contact Stress (LCS) Porocoat Knee Systems

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ClinicalTrials.gov Identifier: NCT00733499
Recruitment Status : Active, not recruiting
First Posted : August 13, 2008
Results First Posted : August 4, 2014
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
DePuy International

Brief Summary:
The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: LCS Complete Duofix Device: LCS Complete Porocoat Phase 4

Detailed Description:
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Single Blinded Study Comparing the Pain, Biological Fixation and Outcomes of Patients With LCS Complete Duofix or LCS Porocoat Knee Systems
Study Start Date : September 2006
Actual Primary Completion Date : October 2009
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
LCS Complete Duofix
102 patients
Device: LCS Complete Duofix
Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
Active Comparator: LCS Complete Porocoat
104 patients
Device: LCS Complete Porocoat
Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces



Primary Outcome Measures :
  1. Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months. [ Time Frame: 6 Months Post Surgery ]
    The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 cementless mobile bearing knee system (LCS Complete).
  • Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with both the investigational devices, 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 affect 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733499


Locations
Ireland
Musgrave Park Hospital
Belfast, Ireland, BT9 7JB
Sponsors and Collaborators
DePuy International

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733499     History of Changes
Other Study ID Numbers: CT 05/28
First Posted: August 13, 2008    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: March 2, 2018
Last Verified: February 2018

Keywords provided by DePuy International:
Arthroplasty, replacement, Knee, LCS Duofix, Porocoat

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases