Pre-Op THA Modelling
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prospective Computer-Navigated Cohort 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
Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
|
| 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
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.
|
Outcome Measures
Primary Outcome Measures
- Acetabular cup position [6 months post-op]
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
- Protrusion length [6 months post-op]
CT examination. Length of protrusion in the sagittal and axial view.
- Acetabular cup loosening [6 months post-op]
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.
- Degree of heterotopic ossification [6 months post-op]
CT examination. Classification of heterotopic ossification based on Brooker Classification.
- Muscle area [6 months post-op]
CT examination measuring muscle cross-sectional area (in mm2).
- Muscle density [6 months post-op]
CT examination measuring radiological density (in HU).
- Capsular scarring [6 months post-op]
MRI examination. Measuring the joint capsule in its thickest part.
- Joint effusion. [6 months post-op]
MRI examination. Grading according to Mitchel et al. 1986
- Quantification of fluid. [6 months post-op]
MRI examination. Grading according to Mitchel et al. 1986
- Heterotopic ossification in periarticular soft tissues. [6 months post-op]
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
- Soft tissue impingement [6 months post-op]
MRI examination. Measuring acetabular angle of anteversion.
- Integrity of the periarticular muscles. [6 months post-op]
MRI examination. Grading based on the Goutallier classification.
Secondary Outcome Measures
- Oxford Hip Score [3- and 6-months post-op]
Joint-specific patient-reported outcome measure of disability in patients following THA
- UCLA Activity Score [3- and 6-months post-op]
Validated 10-point scale evaluating patient activity levels
- VR-12 [3- and 6-months post-op]
Patient-reported outcome measure of patient's overall perspective of their health
- WOMAC questionnaire [3- and 6-months post-op]
Self-administered questionnaire assessing activities of daily living, functional mobility, gait, general health and quality of life.
- Novel questionnaire [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)
- Harris Hip Score [3- and 6-months post-op]
A measure of dysfunction following total hip arthroplasty
Eligibility Criteria
Criteria
Inclusion Criteria:
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osteoarthritis of the hip requiring primary THA
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40 years of age or older
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BMI <40 kg/m2
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able to provide informed consent, able and willing to do study assessments and follow instructions
Exclusion Criteria:
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prior surgery on the indicated hip with insertion of hardware
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prior surgery on the lower spine with insertion of hardware
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hip and/or spinal fixed deformities or inflammatory/ossification processes of the spine (e.g. DISH, ankylosing spondylolisthesis)
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limitations to range of motion of the contralateral hip
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre | London | Ontario | Canada | N6A5A5 |
Sponsors and Collaborators
- Lawson Health Research Institute
- Smith & Nephew, Inc.
Investigators
- Principal Investigator: Brent Lanting, London Health Sciences Centre/Lawson
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11307