Pre-Op THA Modelling

May 8, 2025 updated by: Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Pre-Op Total Hip Arthroplasty Modelling: Individualized Care, Improved Outcomes

Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.

Study Overview

Status

Status

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

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 (Estimated)

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.
80

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
      • London, Ontario, Canada, N6A5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Brent Lanting

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • osteoarthritis of the hip requiring primary THA
  • 40 years of age or older
  • BMI <40 kg/m2
  • able to provide informed consent, able and willing to do study assessments and follow instructions

Exclusion Criteria:

  • prior surgery on the indicated hip with insertion of hardware
  • prior surgery on the lower spine with insertion of hardware
  • hip and/or spinal fixed deformities or inflammatory/ossification processes of the spine (e.g. DISH, ankylosing spondylolisthesis)
  • limitations to range of motion of the contralateral hip

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Prospective Computer-Navigated Cohort
Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.
Procedure: Computer-navigated THA surgery
Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
Active Comparator: Cross-sectional Standard of Care Cohort
Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.
Procedure: Standard of care THA surgery
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

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
Acetabular cup position
Time Frame: 6 months post-op
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
6 months post-op
Protrusion length
Time Frame: 6 months post-op
CT examination. Length of protrusion in the sagittal and axial view.
6 months post-op
Acetabular cup loosening
Time Frame: 6 months post-op
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.
6 months post-op
Degree of heterotopic ossification
Time Frame: 6 months post-op
CT examination. Classification of heterotopic ossification based on Brooker Classification.
6 months post-op
Muscle area
Time Frame: 6 months post-op
CT examination measuring muscle cross-sectional area (in mm2).
6 months post-op
Muscle density
Time Frame: 6 months post-op
CT examination measuring radiological density (in HU).
6 months post-op
Capsular scarring
Time Frame: 6 months post-op
MRI examination. Measuring the joint capsule in its thickest part.
6 months post-op
Joint effusion.
Time Frame: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
6 months post-op
Quantification of fluid.
Time Frame: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
6 months post-op
Heterotopic ossification in periarticular soft tissues.
Time Frame: 6 months post-op
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
6 months post-op
Soft tissue impingement
Time Frame: 6 months post-op
MRI examination. Measuring acetabular angle of anteversion.
6 months post-op
Integrity of the periarticular muscles.
Time Frame: 6 months post-op
MRI examination. Grading based on the Goutallier classification.
6 months post-op

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
Oxford Hip Score
Time Frame: 3- and 6-months post-op
Joint-specific patient-reported outcome measure of disability in patients following THA
3- and 6-months post-op
UCLA Activity Score
Time Frame: 3- and 6-months post-op
Validated 10-point scale evaluating patient activity levels
3- and 6-months post-op
VR-12
Time Frame: 3- and 6-months post-op
Patient-reported outcome measure of patient's overall perspective of their health
3- and 6-months post-op
WOMAC questionnaire
Time Frame: 3- and 6-months post-op
Self-administered questionnaire assessing activities of daily living, functional mobility, gait, general health and quality of life.
3- and 6-months post-op
Novel questionnaire
Time Frame: 3- and 6-months post-op
Self-reported outcome measure that assess the patient's ability to perform 10 common activities of daily living (gait, pivot left, pivot right, upstairs, downstairs, step over, chair sit/rise, bend forward, sit low, and squat)
3- and 6-months post-op
Harris Hip Score
Time Frame: 3- and 6-months post-op
A measure of dysfunction following total hip arthroplasty
3- and 6-months post-op

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.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Smith & Nephew, Inc.

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: Brent Lanting, London Health Sciences Centre/Lawson

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.
August 1, 2022

Primary Completion (Estimated)

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.
November 30, 2025

Study Completion (Estimated)

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.
November 30, 2025

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).
October 27, 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.
February 2, 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.
February 3, 2022

Study Record Updates

Last Update Posted (Actual)

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 13, 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 8, 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

Keywords

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.
  • 11307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings