Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Radiostereometric Analysis (RSA) Study of Implant Stability and Clinical Evaluation of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Simplex High Viscosity Bone Cement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HV Cement<br>Simplex High Viscosity Bone Cement | Device: Simplex High Viscosity Bone Cement<br>* high viscosity bone cement for total knee replacement<br>* Other names: HV Bone Cement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Migration measured with Radiostereometric Analysis (RSA) | Total implant migration will be measured in mm using RSA | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative handling characteristics captured through semi-structured interviews | 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. | intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty