Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02572310
• Lead Sponsor: Michael Dunbar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2016-03
• Primary Completion: 2020-03
• Study Completion: 2020-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada