Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

NCT02572310 | Completed

• 1 other identifier: STR HVC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Implant Migration measured with Radiostereometric Analysis (RSA)

  Total implant migration will be measured in mm using RSA

  2 years

Secondary Outcomes (1)

• Qualitative handling characteristics captured through semi-structured interviews

  intra-operative

Study Arms (1)

HV Cement

EXPERIMENTAL

Simplex High Viscosity Bone Cement

Device: Simplex High Viscosity Bone Cement

Interventions

Simplex High Viscosity Bone Cement DEVICE

high viscosity bone cement for total knee replacement

Also known as: HV Bone Cement

HV Cement

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michael Dunbar: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Dunbar, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: October 8, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)