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Clinical Trials/NCT04378049
NCT04378049
Active, not recruiting
Not Applicable

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

McMaster University1 site in 1 country64 target enrollmentNovember 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
McMaster University
Enrollment
64
Locations
1
Primary Endpoint
Feasibility- Participant retention
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 23, 2020
End Date
December 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility- Participant retention

Time Frame: 12 months

Number of patients completing the study

Feasibility- Treatment compliance

Time Frame: 12 months

The number of crossovers during a 12 month period

Feasibility- Recruitment

Time Frame: 12 months

The number of patients recruited during a 12 month period

Secondary Outcomes

  • Healthcare resource use (for cost-effectiveness)(12 months post-surgery)
  • Rage of motion (ROM)(6 weeks post-surgery)
  • Forgotten joint score(12 months post-surgery)
  • Quality of life- EQ-5D(12 months post-surgery)
  • Persistent post-surgical pain (PPSP)(12 months post-surgery)
  • Patient global impression of change score(12 months post-surgery)
  • Return to function questionnaire(12 months post-surgery)
  • Short-term implant survival(12 months post-surgery)
  • Gait walking mechanics analysis(12 months post-surgery)
  • Knee alignment(Post-surgery)
  • Oxford knee score(12 months post-surgery)
  • Adverse events(12 months post-surgery)

Study Sites (1)

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