Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

Study Overview
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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.

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.

Official Title
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Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Total knee arthroplasty
* Procedure: Robot-assisted partial knee arthroplasty


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard total knee arthroplasty<br>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. | Procedure: Total knee arthroplasty<br>* Surgeon will perform a total knee arthroplasty procedure according to local standard of care<br>* Other names: Total knee replacement;|
| Experimental: Robot-assisted partial knee arthroplasty<br>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 | Procedure: Robot-assisted partial knee arthroplasty<br>* Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure<br>* Other names: MakoPlasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility- Recruitment | The number of patients recruited during a 12 month period | 12 months | 
| Feasibility- Participant retention | Number of patients completing the study | 12 months | 
| Feasibility- Treatment compliance | The number of crossovers during a 12 month period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to function questionnaire | We will use the 5-item Return To Function (RTF) questionnaire to determine when a trial participant returns to work, leisure, and activities around the home after an injury or surgery (measured as time to return to unrestricted activities). | 12 months post-surgery | 
| Oxford knee score | We will measure knee function using the Oxford Knee Score (OKS), which is a validated and well-used 12 item questionnaire used to measure knee function when performing daily activities after total knee replacement surgery. The OKS is scored on a 0-48 scale with higher scores representing a better outcome. | 12 months post-surgery | 
| Forgotten joint score | We will use the Forgotten Joint Score (FJS-Knee) to measure how natural the replaced knee feels. The FJS-Knee is a 12 item questionnaire that aims to assess both function and feeling by asking about patients' awareness of their artificial knee while doing various daily activities. The FJS is scored on a 0-100 scale with higher scores representing a better outcome. | 12 months post-surgery | 
| Gait walking mechanics analysis | Overground walking kinematic gait analysis will be performed in the clinic environment using a ten-camera optoelectronic motion capture system. Primary gait outcomes will include the knee joint flexion and adduction angle magnitudes and range during the stance phase of gait. Secondary gait outcomes will include stride characteristics as defined above, knee transverse rotation during stance, knee flexion during swing, hip and ankle range of motion and peak magnitudes during stance. | 12 months post-surgery | 
| Quality of life- EQ-5D | We will use the Euro-Qol 5 Dimensions (EQ-5D) questionnaire, a widely used and well-validated quality of life tool, to measure participant quality of life. The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire. | 12 months post-surgery | 
| Persistent post-surgical pain (PPSP) | We will use a modified version of the WHO's definition of PPSP, to include a minimum threshold of pain severity: Pain that began after surgery or a tissue trauma; Pain is in an area of preceding surgery or tissue trauma; Pain has persisted for at least three months after surgery; and The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause. ≥4 out of 10 on the numeric rating scale (NRS) from the Brief Pain Inventory (BPI-SF) for average pain over the last week. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine) | 12 months post-surgery | 
| Patient global impression of change score | We will use The Patient Global Impression of Change (PGIC) scale to assess patients' beliefs about the efficacy of treatment. The PGIC is one item and asks patients to rate the effectiveness of the treatment of interest on a 7-point ordinal scale ranging from very much improved to very much worse | 12 months post-surgery | 
| Healthcare resource use (for cost-effectiveness) | We will collect healthcare resource utilization information (e.g. hospitalization, physician visits) and information on productivity (e.g. time missed from work) to assist with health economic analyses. | 12 months post-surgery | 
| Rage of motion (ROM) | We will measure knee ROM using a goniometer at in-clinic visits according to standard practice | 6 weeks post-surgery | 
| Knee alignment | We will measure mechanical alignment on pre-operative and post-operative weightbearing x-rays | Post-surgery | 
| Adverse events | We will collect all serious adverse events and surgery-related non-serious adverse events throughout the trial for safety monitoring purposes | 12 months post-surgery | 
| Short-term implant survival | We will report the number of revision surgeries within the study period including cases of periprosthetic joint infection, aseptic loosening, instability, poly wear, intractable pain, periprosthetic fracture etc. | 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Unicompartmental knee arthroplasty, Robot-assisted surgery, Pilot randomized controlled trial, Bicompartmental knee arthroplasty, Mako partial knee