Clinical trial NCT04600583: 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
Official title: A Prospective, Randomized, Controlled Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement - A Study Using Stryker Mako Robotic-Arm Assisted Technology®.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee
Arthroplasty
Lead sponsor: Stryker South Pacific
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 278
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Joint feeling and Forgotten Joint Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months
Secondary outcomes:
measure: Function and Oxford Knee Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Function and The International Knee Society Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
measure: Function and Knee Injury and Osteoarthritis Outcome Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Pain and Oxford Knee Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Pain and The International Knee Society Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months
measure: Pain and Knee Injury and Osteoarthritis Outcome Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Pain and Visual Analogue Scale
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Satisfaction and Net Promoter Score
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Health related quality of life and Euro-Qol (EQ-5D-3L)
timeFrame: Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months
measure: Early pain
timeFrame: In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months
measure: Early function
timeFrame: In-patient setting (< 5 days post-operation)
measure: Early function
timeFrame: In-patient setting (< 5 days post-operation)
measure: Early function
timeFrame: In-patient setting (< 5 days post-operation)
measure: Early function
timeFrame: In-patient setting (< 5 days post-operation)
measure: Blood loss
timeFrame: Intra-operative
measure: Adjustments to balance
timeFrame: Intra-operative
measure: Ability to reach target knee balance as assessed by alignment angles and gaps
timeFrame: Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months
Other outcomes:
Locations:
city: Takapuna
country: New Zealand
facility: North Shore Hospital
state: Auckland
Study officials:
affiliation: North Shore Hospital
name: Simon Young, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young SW, Zeng N, Tay ML, Fulker D, Esposito C, Carter M, Bayan A, Farrington B, Van Rooyen R, Walker M. A prospective randomised controlled trial of mechanical axis with soft tissue release balancing vs functional alignment with bony resection balancing in total knee replacement-a study using Stryker Mako robotic arm-assisted technology. Trials. 2022 Jul 20;23(1):580. doi: 10.1186/s13063-022-06494-4.