NCT05659329

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis Knee
• Aseptic Loosening

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-25
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2022-12-21
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Regulatory

• FDA-regulated device study