Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Michael Dunbar25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Simplex High Viscosity Bone CementDEVICE

high viscosity bone cement for total knee replacement

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Implant Migration measured with Radiostereometric Analysis (RSA)

Total implant migration will be measured in mm using RSA

Time frame: 2 years

Secondary Outcomes

Qualitative handling characteristics captured through semi-structured interviews

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.

Time frame: intra-operative

Data from ClinicalTrials.gov

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