Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Surgeons cannot be blinded to treatment group. It would not be feasible to blind the health care team and patients because the incisions and imaging are visually distinguishable. We will attempt to minimize bias in subjective measures by presenting patients with balanced information on each treatment group prior to the trial. All participants will receive a computed tomography (CT) scan prior to surgery to maintain blinding and to give surgeons additional information about 3 dimensional modelling for implant placement. Data analysts will be blinded to treatment allocation. An independent outcomes assessor will independently review radiographic alignment for each patient and review relatedness of adverse events and re-operations. The independent assessor cannot be blinded because imaging is visually distinguishable.

Study Groups

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Standard total knee arthroplasty

Participants who are randomized to the control group will undergo TKA according to local standard of care. The choice of implant and use of bone cement will be recorded but left to the surgeon's discretion according to their standard practice.

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type PROCEDURE

Surgeon will perform a total knee arthroplasty procedure according to local standard of care

Robot-assisted partial knee arthroplasty

Participants with isolated medial or isolated lateral compartment OA who are randomized to the intervention group and have one affected knee compartment will receive a robot-assisted unicompartmental knee arthroplasty (UKA). If the patient has medial or lateral OA plus patellofemoral OA they will receive a bicompartmental knee arthroplasty (BiKA) consisting of a two simultaneous UKAs. The partial knee replacement procedures will be performed using the Mako RIO robotic arm (Stryker) according to the manufacturer's instructions. The choice of implant and use of bone cement will be recorded but will be left to the surgeon's discretion. Surgeons will resurface the patella if the patellar cartilage meets Outerbridge grade 3 or 4 criteria

Group Type EXPERIMENTAL

Robot-assisted partial knee arthroplasty

Intervention Type PROCEDURE

Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure

Interventions

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Total knee arthroplasty

Surgeon will perform a total knee arthroplasty procedure according to local standard of care

Intervention Type PROCEDURE

Robot-assisted partial knee arthroplasty

Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure

Intervention Type PROCEDURE

Other Intervention Names

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Total knee replacement MakoPlasty

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No