Retrospective Simplex High Viscosity (HV) Bone Cement Study

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis Knee; Aseptic Loosening
• Intervention / Treatment: Device: Simplex HV

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will include all non-censored subjects who have received the Triathlon total knee system cemented with Simplex HV and are available for objective analysis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-medicated Simplex HV; Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.	Device: Simplex HV; 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.; Other Names: Non-medicated Simplex HV; Gentamycin Simplex HV
Gentamycin Simplex HV; Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.	Device: Simplex HV; 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.; Other Names: Non-medicated Simplex HV; Gentamycin Simplex HV

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): September 27, 2022

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Bone Cement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: 80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes