Pre-Op THA Modelling

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

osteoarthritis of the hip requiring primary THA

40 years of age or older

BMI <40 kg/m2

able to undergo CT

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imageless computer-navigated THA surgery

    Procedure/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 surgery

    Procedure/Surgery

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

  • CT-based Computer-navigated THA surgery

    Procedure/Surgery

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Prospective Imageless Computer-Navigated CohortExperimental treatment 1 intervention
Group B: Cross-sectional Standard of Care CohortActive comparator 1 intervention
Group C: Prospective CT-based Computer-Navigated CohortExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

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