Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572310
• Other study ID #: STR HVC
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2020

Study information

• Verified date: August 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Simplex High Viscosity Bone Cement
high viscosity bone cement for total knee replacement

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Michael Dunbar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Migration measured with Radiostereometric Analysis (RSA)	Total implant migration will be measured in mm using RSA	2 years
Secondary	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.	intra-operative