MedTrace Logo

Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

NCT02572310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-08-09

No results posted yet for this study

Summary

In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.

Conditions

Interventions

DEVICE

Simplex High Viscosity Bone Cement

high viscosity bone cement for total knee replacement

Sponsors & Collaborators

  • Michael Dunbar

    lead OTHER

Principal Investigators

  • Michael Dunbar, PhD · Nova Scotia Health Authority

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-03-31
Completion
2020-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02572310 on ClinicalTrials.gov