A Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement Using Stryker's Mako Robot

N/AActive Not RecruitingNCT04600583

Stryker South Pacific278 enrolled

Overview

This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

278

Conditions

Osteoarthritis

Interventions

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)DEVICE

All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 robotic-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 CT 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 deformity ≥ 15°. * 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).

Locations (1)

North Shore Hospital

Takapuna, Auckland, New Zealand

Outcomes

Primary Outcomes

Joint feeling and Forgotten Joint Score

To evaluate differences in joint feeling assessed via the Forgotten Joint Score. This newly-developed 12-item score ranges from 0 to 100 and assesses how aware recipients are of their joint in everyday life. Higher scores indicate a good outcome i.e. a high degree of forgetting the joint. For the purpose of this study a change in score of 14 points for the Forgotten Joint Score has been identified.

Time frame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months

Secondary Outcomes

Function and Oxford Knee Score

To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Oxford Knee Score. This score ranges from 0 to 48 where a higher score indicates a better outcome.