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/Gentamicin Simplex HV bone cement

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/Gentamicin Simplex HV bone cement; Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing 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.
Gentamicin Simplex HV; Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.	Device: Simplex HV/Gentamicin Simplex HV bone cement; Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Application of Bone Cement	A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS) Pain Motion Score: Range of Motion	The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg).	pre-op, 2 years, 5 years (optional)
KSS Pain Motion Score: Pain	This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects.	Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking Aids	Pre- and postoperative use of walking aids	Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking	Pre- and post-operative walking ability	pre-operative, 2 years, 5 years (optional)
KSS Function Score: Stairs	Pre-and postoperative ability of climbing stairs	Pre-operative, 2 years, 5 years (optional)
Oxford Knee Score (OKS) Results	The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function.	pre-op, 2 years, 5 years (optional)
KSS Pain Motion Score: Stability	This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability < 5 mm and medio-lateral (m/l) stability < 5° means mild increase in laxity compared to the contralateral knee.	pre-operative, 2 years, 5 years (optional)

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Andrew Toms, Prof., PEOC Royal Devon & Exeter Hospital; Principal Investigator: Matthew Hepinstall, MD, Department of Orthopedic Surgery NYU Langone Health

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 (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: July 1, 2025

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