Retrospective Simplex High Viscosity (HV) Bone Cement Study

Study Overview
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Brief Summary
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This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Detailed Description
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This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.

Official Title
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A Retrospective Multicenter Study to Review the Use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Conditions
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Arthritis Knee, Aseptic Loosening

Intervention / Treatment
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* Device: Simplex HV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Patient is age 18 or over at time of study device implantation Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label Patients who have been followed for at least 24 months postoperatively Exclusion Criteria: Patients who have undergone revision surgery Patients who have undergone bilateral Knee Arthroplasty Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use Patient has a cementless tibial baseplate. Patient has an active or suspected latent infection in or about the affected knee joint Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days) Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure Patient is a prisoner

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-medicated Simplex HV<br>Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. | Device: Simplex HV<br>* Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.<br>* Other names: Gentamycin Simplex HV;|
| Gentamycin Simplex HV<br>Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement. | Device: Simplex HV<br>* Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.<br>* Other names: Gentamycin Simplex HV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | To evaluate the success rate of cemented Triathlon Total Knee components implanted using Simplex high viscosity bone cement (Simplex HV). Success is defined as absence of revision due to aseptic loosening in cemented Triathlon Total Knee components implanted with Simplex HV. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) Results | To review KSS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty. | pre-op, 2 years, optional 5 years | 
| Oxford Knee Score (OKS) Results | To review OKS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty. | pre-op, 2 years, optional 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroplasty, Bone Cement