Pre-Op THA Modelling

Study Overview
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Brief Summary
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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.

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

Conditions
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Total Hip Arthroplasty, Computer-Assisted Surgery

Intervention / Treatment
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* Procedure: Computer-navigated THA surgery
* Procedure: Standard of care THA surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Computer-Navigated Cohort<br>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<br>* Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.<br>|
| Active Comparator: Cross-sectional Standard of Care Cohort<br>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<br>* Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | Joint-specific patient-reported outcome measure of disability in patients following THA | 3- and 6-months post-op | 
| UCLA Activity Score | Validated 10-point scale evaluating patient activity levels | 3- and 6-months post-op | 
| VR-12 | Patient-reported outcome measure of patient's overall perspective of their health | 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. | 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) | 3- and 6-months post-op | 
| Harris Hip Score | A measure of dysfunction following total hip arthroplasty | 3- and 6-months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Joint Disease, Musculoskeletal Disease