ClinicalTrials.gg
RecruitingNCT05221554Updated Oct 7, 2026

Pre-Op THA Modelling

An interventional study of Imageless computer-navigated THA surgery and Standard of care THA surgery in Total Hip Arthroplasty and Computer-Assisted Surgery, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 3 months later.
Updated Oct 7, 2026Enrollment updatedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Total Hip Arthroplasty
  • Computer-Assisted Surgery

Keywords

  • Osteoarthritis
  • Joint Disease
  • Musculoskeletal Disease
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 180 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 7, 2026. See what changed

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
  • diagnosis of inflammatory arthroplasty
  • limitations to range of motion of the contralateral hip
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Prospective Imageless Computer-Navigated Cohort

    Patients in this arm will receive standard patient of care implants but imageless navigation software will be used to plan optimal acetabular cup placement.

    Procedure: Imageless computer-navigated THA surgery

  • 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

  • Experimental
    Prospective CT-based Computer-Navigated Cohort

    Patients in this arm will receive standard patient of care implants but computer navigation software will be used to plan optimal acetabular cup placement.

    Procedure: CT-based Computer-navigated THA surgery

Interventions

  • ProcedureImageless computer-navigated THA surgery

    Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.

  • ProcedureStandard of care THA surgery

    Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

  • ProcedureCT-based Computer-navigated THA surgery

    CT- based computer navigation software coupled with modeling software will be used to plan optimal acetabular cup for patients undergoing THA.

06

What researchers measure

Primary outcomes

  1. Acetabular cup position

    CT examination. Measuring acetabular cup inclination and anteversion in degrees.

    Time frame: 6 months post-op

  2. Protrusion length

    CT examination. Length of protrusion in the sagittal and axial view.

    Time frame: 6 months post-op

  3. Acetabular cup loosening

    CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency \> 2 mm in width.

    Time frame: 6 months post-op

  4. Degree of heterotopic ossification

    CT examination. Classification of heterotopic ossification based on Brooker Classification.

    Time frame: 6 months post-op

  5. Muscle area

    CT examination measuring muscle cross-sectional area (in mm2).

    Time frame: 6 months post-op

  6. Muscle density

    CT examination measuring radiological density (in HU).

    Time frame: 6 months post-op

  7. Capsular scarring

    MRI examination. Measuring the joint capsule in its thickest part.

    Time frame: 6 months post-op

  8. Joint effusion.

    MRI examination. Grading according to Mitchel et al. 1986

    Time frame: 6 months post-op

  9. Quantification of fluid.

    MRI examination. Grading according to Mitchel et al. 1986

    Time frame: 6 months post-op

  10. Heterotopic ossification in periarticular soft tissues.

    MRI examination. Classification of heterotopic ossification based on Brooker Classification.

    Time frame: 6 months post-op

  11. Soft tissue impingement

    MRI examination. Measuring acetabular angle of anteversion.

    Time frame: 6 months post-op

  12. Integrity of the periarticular muscles.

    MRI examination. Grading based on the Goutallier classification.

    Time frame: 6 months post-op

Secondary outcomes

  1. Oxford Hip Score

    Joint-specific patient-reported outcome measure of disability in patients following THA

    Time frame: 3- and 6-months post-op

  2. UCLA Activity Score

    Validated 10-point scale evaluating patient activity levels

    Time frame: 3- and 6-months post-op

  3. VR-12

    Patient-reported outcome measure of patient's overall perspective of their health

    Time frame: 3- and 6-months post-op

  4. WOMAC questionnaire

    Self-administered questionnaire assessing activities of daily living, functional mobility, gait, general health and quality of life.

    Time frame: 3- and 6-months post-op

  5. 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)

    Time frame: 3- and 6-months post-op

  6. Harris Hip Score

    A measure of dysfunction following total hip arthroplasty

    Time frame: 3- and 6-months post-op

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Nov 2027, 63 months after the start.

Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 63 months is above that.

Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2021
First posted
Feb 3, 2022
StartActual
Aug 1, 2022
Primary completionEst.
Nov 30, 2027
CompletionEst.
Nov 30, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Enrollment
80→180
Oct 7, 2026
Eligibility
1 inclusion criterion added; 1 exclusion criterion added
What changed in the criteria
Inclusion criteria
  • Addedable to undergo CT
Exclusion criteria
  • Addeddiagnosis of inflammatory arthroplasty
Oct 7, 2026
Interventions
Added Procedure: Imageless computer-navigated THA surgery·Procedure: CT-based Computer-navigated THA surgery; removed Procedure: Computer-navigated THA surgery. Arm changed Prospective Computer-Navigated Cohort→Prospective Imageless Computer-Navigated Cohort. Arms added: Prospective CT-based Computer-Navigated Cohort
Oct 7, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • London Health Sciences Centre · London, CanadaContact added k•••@lhsc.on.ca · •••8500
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Enrollment 80→180
    Eligibility 1 inclusion criterion added; 1 exclusion criterion added
    What changed in the criteria
    Inclusion criteria
    • Addedable to undergo CT
    Exclusion criteria
    • Addeddiagnosis of inflammatory arthroplasty
    Interventions Added Procedure: Imageless computer-navigated THA surgery·Procedure: CT-based Computer-navigated THA surgery; removed Procedure: Computer-navigated THA surgery. Arm changed Prospective Computer-Navigated Cohort→Prospective Imageless Computer-Navigated Cohort. Arms added: Prospective CT-based Computer-Navigated Cohort
    Site contacts Changed at 1 site. See the sites
    Show the site
    • London Health Sciences Centre · London, CanadaContact added k•••@lhsc.on.ca · •••8500
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05221554
Responsible party
Brent Lanting (Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Feb 3, 2022
Start date
Aug 1, 2022
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Brent Lanting
Contact
Brent.Lanting@lhsc.on.ca
519-663-3335
Lyndsay Somerville
Contact
Lyndsay.Somerville@lhsc.on.ca
519-685-8500 ext. 36645
Brent Lanting
principal investigator · London Health Sciences Centre/Lawson

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion