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Retrospective Simplex High Viscosity (HV) Bone Cement Study

NCT05659329 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-12

Study results available
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Summary

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

Conditions

  • Arthritis Knee
  • Aseptic Loosening

Interventions

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.

Sponsors & Collaborators

  • Stryker Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Andrew Toms, Prof. · PEOC Royal Devon & Exeter Hospital

  • Matthew Hepinstall, MD · Department of Orthopedic Surgery NYU Langone Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-25
Primary Completion
2022-09-27
Completion
2022-09-27
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659329 on ClinicalTrials.gov