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

January 6, 2020 updated by: DePuy International

A Prospective, Randomised, Single Blinded Study Comparing the Pain, Biological Fixation and Outcomes of Patients With LCS Complete Duofix or LCS Porocoat Knee Systems

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Belfast, Ireland, BT9 7JB
        • Musgrave Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Time Frame: 12 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
12 Months Post Surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.
Time Frame: Pre-op
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
Pre-op
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
Time Frame: 3 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
3 months
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
Time Frame: 6 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
6 months
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Time Frame: 12 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
12 months
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
Time Frame: 24 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
24 months
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
Time Frame: 60 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
60 months
Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
Time Frame: 120 months
The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.
120 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.
Time Frame: pre-op
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
pre-op
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
Time Frame: 3 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
3 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
Time Frame: 6 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
6 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Time Frame: 12 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
12 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
Time Frame: 24 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
24 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
Time Frame: 60 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
60 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
Time Frame: 120 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
120 months
Survivorship Analysis
Time Frame: 5 Years
The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.
5 Years
Survivorship Analysis
Time Frame: 9.99 years
The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.
9.99 years
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Preop.
Time Frame: preop
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
preop
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.
Time Frame: 3 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
3 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
Time Frame: 6 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
6 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.
Time Frame: 12 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
12 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.
Time Frame: 24 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
24 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.
Time Frame: 60 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
60 months
Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.
Time Frame: 120 months
The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
120 months
Number of Participants With Tibial Radiolucency, 0-1mm
Time Frame: 3 months to 120 months
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.
3 months to 120 months
Number of Participants With Tibial Radiolucency, 1mm-2mm
Time Frame: 3 months to 120 months
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.
3 months to 120 months
Number of Participants With Tibial Radiolucency, Greater Than 2mm
Time Frame: 3 months to 120 months
Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.
3 months to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT 05/28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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