Retrospective Simplex High Viscosity (HV) Bone Cement Study

Completed

• Conditions: Aseptic Loosening; Arthritis Knee
• Interventions: Device: Simplex HV

• Registration Number: NCT05659329
• Lead Sponsor: Stryker Orthopaedics

Brief Summary

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

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 Timeline

• Study Start: 2016-04-25
• Primary Completion: 2022-09-27
• Study Completion: 2022-09-27
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gentamycin Simplex HV	Simplex HV	Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Non-medicated Simplex HV	Simplex HV	Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.

Primary Outcome Measures

Name	Time	Method
Success rate	24 months	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.

Secondary Outcome Measures

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