Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement (RoboKnees)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Total knee arthroplasty; Procedure: Robot-assisted partial knee arthroplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Madden, PhD; Phone Number: 289-237-7380; Email: maddenk@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Kim Madden, PhD; Email: maddenk@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton; Canadian Institutes of Health Research (CIHR); Hamilton Academic Health Sciences Organization
• Investigators: Principal Investigator: Anthony Adili, MD, P.Eng, FRCSC, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Unicompartmental knee arthroplasty; Robot-assisted surgery; Pilot randomized controlled trial; Bicompartmental knee arthroplasty; Mako partial knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RoboKnees

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share data upon reasonable request for non-commercial purposes. This may require an institutional data-sharing agreement.
• IPD Sharing Time Frame: Upon study completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No