Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

A Prospective Radiostereometric Analysis (RSA) Study of Implant Stability and Clinical Evaluation of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02572310

Enrollment

Registered

2015-10-08

Start date

2016-03-31

Completion date

2020-11-30

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total knee arthroplasty

Brief 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.

Interventions

DEVICESimplex High Viscosity Bone Cement

high viscosity bone cement for total knee replacement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Symptomatic arthritis of the knee indicating primary total knee arthroplasty * Between the ages of 21 and 80 inclusive * Patients willing and able to comply with follow-up requirements and self-evaluations * Ability to give informed consent

Exclusion criteria

* Active or prior infection * Medical condition precluding major surgery * Severe osteoporosis or osteopenia * Neuromuscular impairment * Significant co-morbidity affecting ability to ambulate

Design outcomes

Primary

Measure	Time frame	Description
Implant Migration measured with Radiostereometric Analysis (RSA)	2 years	Total implant migration will be measured in mm using RSA

Secondary

Measure	Time frame	Description
Qualitative handling characteristics captured through semi-structured interviews	intra-operative	A qualitative methodology will be used to perform content analysis of the audio from the interviews stored in computer-assisted qualitative data analysis software. The content analysis will involve the use of a deductive approach to the interviews. The coding strategies will derived from a predetermined list of important qualities of bone cement and common themes will be identified as important for the usability of the new cement.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026