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NCT Number: NCT05221554

Pre-Op THA Modelling

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.

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Key information

Conditions

Total Hip Arthroplasty Arthritis Computer-assisted Surgery Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location status: Recruiting

Location contact

Brent Lanting

PRINCIPAL_INVESTIGATOR

Lyndsay Somerville, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-navigated THA surgery

Procedure

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

Standard of care THA surgery

Procedure

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

Primary outcomes

  1. Acetabular cup position

    Time frame: 6 months post-op

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

  2. Protrusion length

    Time frame: 6 months post-op

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

  3. Acetabular cup loosening

    Time frame: 6 months post-op

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

  4. Degree of heterotopic ossification

    Time frame: 6 months post-op

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

  5. Muscle area

    Time frame: 6 months post-op

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

  6. Muscle density

    Time frame: 6 months post-op

    CT examination measuring radiological density (in HU).

  7. Capsular scarring

    Time frame: 6 months post-op

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

  8. Joint effusion.

    Time frame: 6 months post-op

    MRI examination. Grading according to Mitchel et al. 1986

  9. Quantification of fluid.

    Time frame: 6 months post-op

    MRI examination. Grading according to Mitchel et al. 1986

  10. Heterotopic ossification in periarticular soft tissues.

    Time frame: 6 months post-op

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

  11. Soft tissue impingement

    Time frame: 6 months post-op

    MRI examination. Measuring acetabular angle of anteversion.

  12. Integrity of the periarticular muscles.

    Time frame: 6 months post-op

    MRI examination. Grading based on the Goutallier classification.

Secondary outcomes

  1. Oxford Hip Score

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

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

  2. UCLA Activity Score

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

    Validated 10-point scale evaluating patient activity levels

  3. VR-12

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

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

  4. 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.

  5. 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)

  6. Harris Hip Score

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

    A measure of dysfunction following total hip arthroplasty

Study contacts

Contact information is provided by the study sponsor or research team.

Brent Lanting

CONTACT

[email protected]

519-663-3335

Lyndsay Somerville

CONTACT

[email protected]

519-685-8500 ext. 36645

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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