Total Hip ArthroplastyNCT05221554
Pre-Op THA Modelling
A study testing Imageless computer-navigated THA surgery and CT-based Computer-navigated THA surgery in people with Total Hip Arthroplasty and Computer-Assisted Surgery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Total Hip Arthroplasty, Computer-Assisted Surgery
- What is being tested?
- Imageless computer-navigated THA surgery and CT-based Computer-navigated THA surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the hip requiring primary THA
- 40 years of age or older
- BMI <40 kg/m2
- able to undergo CT
- able to provide informed consent, able and willing to do study assessments and follow instructions
Who cannot join
- 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)
- diagnosis of inflammatory arthroplasty
- limitations to range of motion of the contralateral hip
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5A5
Lyndsay Somerville, PhD, lyndsay.somerville@lhsc.on.ca
Krysten Virag, 519-685-8500 ext. 32789, krysten.virag@lhsc.on.ca
About this study
Official title: 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.
- Conditions
- Total Hip Arthroplasty, Computer-Assisted Surgery
- Being tested
- Imageless computer-navigated THA surgery, Standard of care THA surgery, CT-based Computer-navigated THA surgery
- Keywords
- Osteoarthritis, Joint Disease, Musculoskeletal Disease
- Medical subject headings
- Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imageless computer-navigated THA surgeryProcedure or surgery
Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
Standard of care THA surgeryProcedure or surgery
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.
CT-based Computer-navigated THA surgeryProcedure or surgery
CT- based computer navigation software coupled with modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Imageless Computer-Navigated Cohort | Experimental | Patients in this arm will receive standard patient of care implants but imageless navigation software will be used to plan optimal acetabular cup placement. Receives: Procedure: Imageless computer-navigated THA surgery |
| Cross-sectional Standard of Care Cohort | Active comparator | Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty. Receives: Procedure: Standard of care THA surgery |
| Prospective CT-based Computer-Navigated Cohort | Experimental | Patients in this arm will receive standard patient of care implants but computer navigation software will be used to plan optimal acetabular cup placement. Receives: Procedure: CT-based Computer-navigated THA surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular cup position
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
Measured: 6 months post-op
Protrusion length
CT examination. Length of protrusion in the sagittal and axial view.
Measured: 6 months post-op
Acetabular cup loosening
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.
Measured: 6 months post-op
Degree of heterotopic ossification
CT examination. Classification of heterotopic ossification based on Brooker Classification.
Measured: 6 months post-op
Muscle area
CT examination measuring muscle cross-sectional area (in mm2).
Measured: 6 months post-op
Muscle density
CT examination measuring radiological density (in HU).
Measured: 6 months post-op
Capsular scarring
MRI examination. Measuring the joint capsule in its thickest part.
Measured: 6 months post-op
Joint effusion.
MRI examination. Grading according to Mitchel et al. 1986
Measured: 6 months post-op
Quantification of fluid.
MRI examination. Grading according to Mitchel et al. 1986
Measured: 6 months post-op
Heterotopic ossification in periarticular soft tissues.
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
Measured: 6 months post-op
Soft tissue impingement
MRI examination. Measuring acetabular angle of anteversion.
Measured: 6 months post-op
Integrity of the periarticular muscles.
MRI examination. Grading based on the Goutallier classification.
Measured: 6 months post-op
Secondary outcomes (6)
Oxford Hip Score
Joint-specific patient-reported outcome measure of disability in patients following THA
Measured: 3- and 6-months post-op
UCLA Activity Score
Validated 10-point scale evaluating patient activity levels
Measured: 3- and 6-months post-op
VR-12
Patient-reported outcome measure of patient's overall perspective of their health
Measured: 3- and 6-months post-op
WOMAC questionnaire
Self-administered questionnaire assessing activities of daily living, functional mobility, gait, general health and quality of life.
Measured: 3- and 6-months post-op
Novel questionnaire
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)
Measured: 3- and 6-months post-op
Harris Hip Score
A measure of dysfunction following total hip arthroplasty
Measured: 3- and 6-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Aug 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brent Lanting, Principal investigator, London Health Sciences Centre/Lawson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221554
- Sponsor's protocol ID
- 11307
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Op Total Hip Arthroplasty Modelling: Individualized Care, Improved Outcomes
- ClinicalTrials.gov ID
- NCT05221554
- Acronym / sponsor ID
- 11307
- Conditions
- Total Hip Arthroplasty, Computer-Assisted Surgery
- Keywords
- Osteoarthritis, Joint Disease, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Imageless Computer-Navigated Cohort | Experimental | Procedure: Imageless computer-navigated THA surgeryPatients in this arm will receive standard patient of care implants but imageless navigation software will be used to plan optimal acetabular cup placement. |
| Cross-sectional Standard of Care Cohort | Active comparator | Procedure: Standard of care THA surgeryPatients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty. |
| Prospective CT-based Computer-Navigated Cohort | Experimental | Procedure: CT-based Computer-navigated THA surgeryPatients in this arm will receive standard patient of care implants but computer navigation software will be used to plan optimal acetabular cup placement. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- osteoarthritis of the hip requiring primary THA
- 40 years of age or older
- BMI <40 kg/m2
- able to undergo CT
- able to provide informed consent, able and willing to do study assessments and follow instructions
Key exclusion criteria (5 listed)
- 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)
- diagnosis of inflammatory arthroplasty
- limitations to range of motion of the contralateral hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imageless computer-navigated THA surgeryNavigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA. | Procedure or surgery | Prospective Imageless Computer-Navigated Cohort |
| Standard of care THA surgeryPatients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation. | Procedure or surgery | Cross-sectional Standard of Care Cohort |
| CT-based Computer-navigated THA surgeryCT- based computer navigation software coupled with modeling software will be used to plan optimal acetabular cup for patients undergoing THA. | Procedure or surgery | Prospective CT-based Computer-Navigated Cohort |
Primary outcome
Acetabular cup position
Time frame: 6 months post-op
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
Protrusion length
Time frame: 6 months post-op
CT examination. Length of protrusion in the sagittal and axial view.
Acetabular cup loosening
Time frame: 6 months post-op
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.
Degree of heterotopic ossification
Time frame: 6 months post-op
CT examination. Classification of heterotopic ossification based on Brooker Classification.
Muscle area
Time frame: 6 months post-op
CT examination measuring muscle cross-sectional area (in mm2).
Muscle density
Time frame: 6 months post-op
CT examination measuring radiological density (in HU).
Capsular scarring
Time frame: 6 months post-op
MRI examination. Measuring the joint capsule in its thickest part.
Joint effusion.
Time frame: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
Quantification of fluid.
Time frame: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
Heterotopic ossification in periarticular soft tissues.
Time frame: 6 months post-op
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
Soft tissue impingement
Time frame: 6 months post-op
MRI examination. Measuring acetabular angle of anteversion.
Integrity of the periarticular muscles.
Time frame: 6 months post-op
MRI examination. Grading based on the Goutallier classification.
6 secondary outcomes
Oxford Hip Score
Time frame: 3- and 6-months post-op
UCLA Activity Score
Time frame: 3- and 6-months post-op
VR-12
Time frame: 3- and 6-months post-op
WOMAC questionnaire
Time frame: 3- and 6-months post-op
Novel questionnaire
Time frame: 3- and 6-months post-op
Harris Hip Score
Time frame: 3- and 6-months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brent Lanting principal investigator
London Health Sciences Centre/Lawson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imageless computer-navigated THA surgery and CT-based Computer-navigated THA surgery in people with Total Hip Arthroplasty and Computer-Assisted Surgery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brent Lanting (519-663-3335, Brent.Lanting@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular cup position (time frame: 6 months post-op). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.