Total Knee Replacement for Functional Independence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
North York General Hospital, Toronto, Canada
Functional Independence+3 More
Total Knee Replacement - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is examining how surgical alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Total Knee Replacement is used to treat Functional Independence. No patients in this trial will receive a placebo. Total Knee Replacement has previously been approved by the FDA for a different condition. The current study is being conducted to see if the treatment is effective for Functional Independence.

Eligible Conditions

  • Functional Independence
  • Pain, Postoperative
  • Total Knee Replacement Surgery

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: post-operatively at 1 year

Post-operatively at 2 years
Pain intensity and effectiveness of analgesics
Satisfaction with knee surgery
Post-operatively at 6 weeks
Health Care Utilization
post-operatively at 1 year
Quality of Life following knee surgery
post-operatively at 2 years
Function

Trial Safety

Safety Progress

1 of 3

Side Effects for

Total (Control)
12%Knee stiff
4%Revision knee arthroplasty
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01140815) in the Total (Control) ARM group. Side effects include: Knee stiff with 12%, Revision knee arthroplasty with 4%.

Trial Design

3 Treatment Groups

Manual Adjusted Mechanical Alignment
1 of 3
Robotic Assisted Kinematic Alignment: (Joint line restoration)
1 of 3
Robotic Assisted Adjusted Mechanical Alignment
1 of 3
Active Control
Experimental Treatment

300 Total Participants · 3 Treatment Groups

Primary Treatment: Total Knee Replacement · No Placebo Group · N/A

Robotic Assisted Kinematic Alignment: (Joint line restoration)
Procedure
Experimental Group · 1 Intervention: Total Knee Replacement · Intervention Types: Procedure
Robotic Assisted Adjusted Mechanical Alignment
Procedure
Experimental Group · 1 Intervention: Total Knee Replacement · Intervention Types: Procedure
Manual Adjusted Mechanical Alignment
Procedure
ActiveComparator Group · 1 Intervention: Total Knee Replacement · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Replacement
2018
Completed Phase 4
~1490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operatively at 1 year
Closest Location: North York General Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2003First Recorded Clinical Trial
1 TrialsResearching Functional Independence
44 CompletedClinical Trials

Who is running the clinical trial?

North York General HospitalLead Sponsor
19 Previous Clinical Trials
8,688 Total Patients Enrolled
Frank Mastrogiacomo, PhDPrincipal InvestigatorNorth York General Hospital

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.