Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HV Cement

Simplex High Viscosity Bone Cement

Group Type EXPERIMENTAL

Simplex High Viscosity Bone Cement

Intervention Type DEVICE

high viscosity bone cement for total knee replacement

Interventions

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Simplex High Viscosity Bone Cement

high viscosity bone cement for total knee replacement

Intervention Type DEVICE

Other Intervention Names

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HV Bone Cement

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No