Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

May 15, 2025 updated by: Mary Rahmat, North York General Hospital
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • undergoing unilateral TKR for the treatment of osteoarthritis
  • between the age of 18 and 85 years of age
  • able to read, speak and understand English, have a telephone
  • are able to provide consent

Exclusion Criteria:

  • enrolled in another study, are
  • undergoing revision surgery or bilateral surgery, and are
  • over the age of 85 years. Patients will also be excluded if they
  • have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Manual Adjusted Mechanical Alignment

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
Procedure: Total Knee Replacement
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.
Other Names:
  • Manual Adjusted Mechanical Alignment
  • Robotic Assisted Adjusted Mechanical Alignment
  • Robotic Assisted Kinematic Alignment: (Joint line restoration)
Experimental: Robotic Assisted Adjusted Mechanical Alignment
  • 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
Procedure: Total Knee Replacement
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.
Other Names:
  • Manual Adjusted Mechanical Alignment
  • Robotic Assisted Adjusted Mechanical Alignment
  • Robotic Assisted Kinematic Alignment: (Joint line restoration)
Experimental: Robotic Assisted Kinematic Alignment: (Joint line restoration)

-- 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
Procedure: Total Knee Replacement
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.
Other Names:
  • Manual Adjusted Mechanical Alignment
  • Robotic Assisted Adjusted Mechanical Alignment
  • Robotic Assisted Kinematic Alignment: (Joint line restoration)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Function
Time Frame: post-operatively 1 year
Oxford knee score
post-operatively 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life following knee surgery
Time Frame: post-operatively at 2 years
EuroQol 5D index
post-operatively at 2 years
Quality of Life following knee surgery
Time Frame: post-operatively at 6 weeks
EuroQol 5D index
post-operatively at 6 weeks
Quality of Life following knee surgery
Time Frame: post-operatively at 6 months
EuroQol 5D index
post-operatively at 6 months
Quality of Life following knee surgery
Time Frame: post-operatively at 1 year
EuroQol 5D index
post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Time Frame: Post-operatively at 6 weeks
Brief Pain Inventory-Short Form - Pain Severity Index
Post-operatively at 6 weeks
Pain intensity and effectiveness of analgesics
Time Frame: Post-operatively at 6 months
Brief Pain Inventory-Short Form - Pain Severity Index
Post-operatively at 6 months
Pain intensity and effectiveness of analgesics
Time Frame: Post-operatively at 1 year
Brief Pain Inventory-Short Form - Pain Severity Index
Post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Time Frame: Post-operatively at 2 years
Brief Pain Inventory-Short Form - Pain Severity Index
Post-operatively at 2 years
Satisfaction with knee surgery
Time Frame: Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score
Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Satisfaction with knee surgery
Time Frame: Post-operatively at 6 weeks
Forgotten Joint Score
Post-operatively at 6 weeks
Satisfaction with knee surgery
Time Frame: Post-operatively at 6 months
Forgotten Joint Score
Post-operatively at 6 months
Satisfaction with knee surgery
Time Frame: Post-operatively at 1 year
Forgotten Joint Score
Post-operatively at 1 year
Satisfaction with knee surgery
Time Frame: Post-operatively at 2 years
Forgotten Joint Score
Post-operatively at 2 years
Function
Time Frame: post-operatively at 6 weeks
Oxford knee score
post-operatively at 6 weeks
Function
Time Frame: post-operatively at 6 months
Oxford knee score
post-operatively at 6 months
Function
Time Frame: pre-operatively
Oxford knee score
pre-operatively
Function
Time Frame: post-operatively at 2 years
Oxford knee score
post-operatively at 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Care Utilization
Time Frame: Post-operatively at 6 weeks
unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery
Post-operatively at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North York General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Mastrogiacomo, PhD, North York General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYGH REB #21-0043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Knowledge translation will occur utilizing a variety of mechanisms. The results of this study will be disseminated at the Canadian Orthopaedic Association conference. They will also be published in an high impact journal. At the provincial level, the data from this study will be shared with Health Quality Ontario, as a requirement of the bundled care program. At the local level, the investigators will disseminate the results of this study as aggregate data at North York General Hospital with to the health care practitioners and administrators involved with caring for the arthroplasty patient population.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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