Knee-Fix study : A prospective, randomised, controlled trial of cemented vs uncemented total knee replacement. A study comparing Stryker Triathlon TKR

orth Shore Hospital Waitemata DHB0 sites316 target enrollmentNovember 24, 2016

Overview

No summary available.

Registry

who.int

Start Date

November 24, 2016

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

orth Shore Hospital Waitemata DHB

•\*The patient is a male or non\-pregnant female between the ages of 40\-75 years.
•\*Patient is deemed appropriate for a cruciate retaining knee replacement.
•\*The patient has a primary diagnosis of osteoarthritis (OA).
•\*The patient has intact collateral ligaments.
•\*The patient has signed the study specific, ethics\-approved, Informed Consent document.
•\*The patient is willing and able to comply with the specified pre\-operative and post\-operative clinical and radiographic evaluations.

•\* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
•\* Patient has had a previous osteotomy around the knee.
•\* The patient is morbidly obese (BMI greater than 41\).
•\* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
•\* The patient has a varus/valgus malalignment greater than 20 degrees (relative to mechanical axis).
•\* The patient has a fixed flexion deformity greater than 20 degrees.
•\* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•\* The patient has a systemic or metabolic disorder leading to progressive bone deterioration or poor bone quality.
•\* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
•\* Patient has a cognitive impairment, an intellectual disability or a mental illness.