← Back to Search

Procedure

Total Knee Replacement for Osteoarthritis

N/A
Recruiting
Led By Frank Mastrogiacomo, PhD
Research Sponsored by North York General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing unilateral TKR for the treatment of osteoarthritis
Between the age of 18 and 85 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operatively at 1 year
Awards & highlights

Study Summary

This trial is examining how surgical alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis.

Who is the study for?
This trial is for adults aged 18-85 with osteoarthritis who need a knee replacement and can communicate in English. They must be able to consent, have a phone, and not be part of another study or needing revision or bilateral surgery.Check my eligibility
What is being tested?
The study tests two ways of aligning the knee joint in replacements: traditional mechanical alignment versus kinematic alignment using robotics. It looks at how each affects function, pain, mood, and fatigue post-surgery over periods up to 2 years.See study design
What are the potential side effects?
Knee replacement surgery may cause pain, swelling, stiffness, infection risk at the surgical site; blood clots; breathing difficulties; nausea from anesthesia; and potential allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are having surgery on only one knee to treat osteoarthritis.
Select...
You are between 18 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operatively at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operatively at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Function
Pain intensity and effectiveness of analgesics
Quality of Life following knee surgery
+1 more
Other outcome measures
Health Care Utilization

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01140815
12%
Revision knee arthroplasty
4%
Knee stiff
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deuce (Study)
Total (Control)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Robotic Assisted Kinematic Alignment: (Joint line restoration)Experimental Treatment1 Intervention
-- Midline incision, no tourniquet, medial parapatellar arthrotomy, resect anterior osteophytes Place femoral pins in proximal incision, tibial pins 4 finger breadths under joint line Map and evaluate the knee, ROM, varus valgus testing at 0 & 90 degrees flexion Distal femoral cut based on cartilage loss on medial and lateral femoral condyle (9mm total cut/condyle). Perform distal femoral cut, maintain the joint line (femoral axis +/- 5 degrees) Perform proximal tibial cut within +/- 3 degrees, balance the gaps, differential between medial and lateral gaps = 1- 3mm. Assess extension space, resect posterior osteophytes Remap posterior condylar axis, place 4 in 1 at 0 degrees to the post condylar axis (aim = 9mm posterior condylar cuts) Resect posterior osteophytes, place trial components. Adjust cuts to achieve a balanced knee, maintain HKA axis +/- 3 degrees Patellar replacement per surgeon discretion Cement the components with tourniquet inflation
Group II: Robotic Assisted Adjusted Mechanical AlignmentExperimental Treatment1 Intervention
Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes Place the femoral pins in the proximal incision and the tibial pins 4 finger breadths under the joint line Map the knee and perform evaluation Assess gaps, adjust the femoral axis to decrease soft tissue release (+/- 2 degrees), correct for flexion contracture Verify and perform distal femoral cut, proximal tibial cut orthogonal (90 Degrees) to the tibial axis Assess and balance extension gap with appropriate releases Remap the posterior condylar axis, assess the flexion space, 3 degrees external rotation to the posterior condylar axis Perform anterior, posterior and chamber cuts with the 4 in 1 (appropriate external rotation), followed by posterior osteophyte resection Place trial components and balance the knee, soft tissue releases (1-2 mm) Patellar replacement based on surgeon's discretion Cementing the components with tourniquet inflation
Group III: Manual Adjusted Mechanical AlignmentActive Control1 Intervention
Usual care: Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes Distal femoral cut with 3-5 degrees of valgus from the anatomical axis (Based on the angle measurement on the 4 foot standing Xray). Correct for flexion contracture. Measure the femoral size with the anterior referencing guides. Use 3 degrees external rotation to the Posterior condylar axis Perform anterior, posterior and chamfer cuts with the 4 in 1 in appropriate external rotation Extramedullary tibial alignment guide with 3-5 degrees posterior slope, and orthogonal cut to the tibial axis. Resect posterior osteophytes Place trial components and perform appropriate release/balance the gaps Patellar replacement based on surgeon's discretion Cementing the components with tourniquet inflation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Replacement
2018
Completed Phase 4
~1490

Find a Location

Who is running the clinical trial?

North York General HospitalLead Sponsor
20 Previous Clinical Trials
8,585 Total Patients Enrolled
1 Trials studying Postoperative Pain
156 Patients Enrolled for Postoperative Pain
Frank Mastrogiacomo, PhDPrincipal InvestigatorNorth York General Hospital

Media Library

Total Knee Replacement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05490186 — N/A
Postoperative Pain Research Study Groups: Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration)
Postoperative Pain Clinical Trial 2023: Total Knee Replacement Highlights & Side Effects. Trial Name: NCT05490186 — N/A
Total Knee Replacement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490186 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are currently participating in the experiment?

"Affirmative. The clinicaltrials.gov website demonstrates that this trial is currently enlisting participants, which began on November 16th 2021 and most recently updated August 3rd 2022. 300 subjects are being sought at a single site of recruitment."

Answered by AI

Is this medical experiment limited to a certain age demographic, or are seniors invited to participate too?

"This clinical trial requires that participants are aged 18-80. There is a total of 99 trials for those under the legal age of consent and 967 for individuals above 65 years old."

Answered by AI

Are there any remaining slots available for participants to join in this research?

"Affirmative. According to clinicaltrials.gov, this research endeavor is presently seeking volunteers; it was initially posted on November 16th 2021 and amended most recently on August 3rd 2022. The trial requires 300 participants from a single site."

Answered by AI

Am I eligible to join the cohort of this research trial?

"In order to be included in this clinical trial, potential participants must demonstrate a certain level of autonomy and fall within the age range of 18-80. Additionally, 300 patients are needed for the study."

Answered by AI
~90 spots leftby Mar 2025