A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes

This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.

Inclusion Criteria:

• The patient is a male or non-pregnant female between the ages of 40-80 years.
• The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
• 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 is able to undergo MRI scanning of the affected limb.
• 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.

Exclusion Criteria:

• 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 ≥ 40).
• 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 ≥ 15° (relative to mechanical axis).
• The patient has a fixed flexion deformity ≥ 15°.
• 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.
• 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.
• The patient is pregnant.
• The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
• The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).