Clinical trial NCT04378049: Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement
Official title: Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty
Unicompartmental knee arthroplasty
Robot-assisted surgery
Pilot randomized controlled trial
Bicompartmental knee arthroplasty
Mako partial knee
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: Hamilton Academic Health Sciences Organization
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-05-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

Detailed description: Knee osteoarthritis (OA) pain is an important source of morbidity and cost to the health care system. Over 60,000 knee replacement surgeries are performed in Canada every year, making it the second most common surgery. Our institution (St. Joseph's Healthcare Hamilton) is the first hospital in Canada to purchase a Mako RIO orthopaedic robot to assist with performing knee replacements. The knee is divided into three compartments, and one, two, or all three compartments can become arthritic. Over 90% of patients with end-stage knee OA receive a total knee replacement (also known as total knee arthroplasty or TKA) even if they have one or two healthy knee compartments. Partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. For this reason, few surgeons are experts at partial knee replacements. We believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. This may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for Canadians. This will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.

Eligibility criteria: Inclusion criteria

* Adult (18+)
* Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
* Two study surgeons independently agree that the patient is eligible for either treatment group

Exclusion criteria

* Inability to provide informed consent (e.g. cognitive disability, language barrier)
* Revision knee surgery
* Simultaneous bilateral knee surgery
* Previous major knee surgery or trauma
* The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
* A CT scan cannot be obtained prior to surgery
* Patient does not wish to participate

Primary outcomes:
measure: Feasibility- Recruitment
timeFrame: 12 months
measure: Feasibility- Participant retention
timeFrame: 12 months
measure: Feasibility- Treatment compliance
timeFrame: 12 months
Secondary outcomes:
measure: Return to function questionnaire
timeFrame: 12 months post-surgery
measure: Oxford knee score
timeFrame: 12 months post-surgery
measure: Forgotten joint score
timeFrame: 12 months post-surgery
measure: Gait walking mechanics analysis
timeFrame: 12 months post-surgery
measure: Quality of life- EQ-5D
timeFrame: 12 months post-surgery
measure: Persistent post-surgical pain (PPSP)
timeFrame: 12 months post-surgery
measure: Patient global impression of change score
timeFrame: 12 months post-surgery
measure: Healthcare resource use (for cost-effectiveness)
timeFrame: 12 months post-surgery
measure: Rage of motion (ROM)
timeFrame: 6 weeks post-surgery
measure: Knee alignment
timeFrame: Post-surgery
measure: Adverse events
timeFrame: 12 months post-surgery
measure: Short-term implant survival
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Anthony Adili, MD, P.Eng, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: