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Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572310
Recruitment Status : Active, not recruiting
First Posted : October 8, 2015
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Dunbar, Nova Scotia Health Authority

Brief Summary:
In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Simplex High Viscosity Bone Cement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Radiostereometric Analysis (RSA) Study of Implant Stability and Clinical Evaluation of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: HV Cement
Simplex High Viscosity Bone Cement
Device: Simplex High Viscosity Bone Cement
high viscosity bone cement for total knee replacement
Other Name: HV Bone Cement




Primary Outcome Measures :
  1. Implant Migration measured with Radiostereometric Analysis (RSA) [ Time Frame: 2 years ]
    Total implant migration will be measured in mm using RSA


Secondary Outcome Measures :
  1. Qualitative handling characteristics captured through semi-structured interviews [ Time Frame: intra-operative ]
    A qualitative methodology will be used to perform content analysis of the audio from the interviews stored in computer-assisted qualitative data analysis software. The content analysis will involve the use of a deductive approach to the interviews. The coding strategies will derived from a predetermined list of important qualities of bone cement and common themes will be identified as important for the usability of the new cement.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic arthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion Criteria:

  • Active or prior infection
  • Medical condition precluding major surgery
  • Severe osteoporosis or osteopenia
  • Neuromuscular impairment
  • Significant co-morbidity affecting ability to ambulate

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): NCT02572310


Locations
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Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Michael Dunbar
Investigators
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Principal Investigator: Michael Dunbar, PhD Nova Scotia Health Authority
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Responsible Party: Michael Dunbar, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02572310    
Other Study ID Numbers: STR HVC
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michael Dunbar, Nova Scotia Health Authority:
total knee arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases