Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04378049

Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
McMaster University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETotal knee arthroplastySurgeon will perform a total knee arthroplasty procedure according to local standard of care
PROCEDURERobot-assisted partial knee arthroplastySurgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure

Timeline

Start date
2020-11-23
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2020-05-07
Last updated
2025-05-09

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04378049. Inclusion in this directory is not an endorsement.