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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.
London Health Sciences Centre
London, Ontario, Canada
RECRUITINGAcetabular cup position
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
Time frame: 6 months post-op
Protrusion length
CT examination. Length of protrusion in the sagittal and axial view.
Time frame: 6 months post-op
Acetabular cup loosening
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency \> 2 mm in width.
Time frame: 6 months post-op
Degree of heterotopic ossification
CT examination. Classification of heterotopic ossification based on Brooker Classification.
Time frame: 6 months post-op
Muscle area
CT examination measuring muscle cross-sectional area (in mm2).
Time frame: 6 months post-op
Muscle density
CT examination measuring radiological density (in HU).
Time frame: 6 months post-op
Capsular scarring
MRI examination. Measuring the joint capsule in its thickest part.
Time frame: 6 months post-op
Joint effusion.
MRI examination. Grading according to Mitchel et al. 1986
Time frame: 6 months post-op
Quantification of fluid.
MRI examination. Grading according to Mitchel et al. 1986
Time frame: 6 months post-op
Heterotopic ossification in periarticular soft tissues.
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
Time frame: 6 months post-op
Soft tissue impingement
MRI examination. Measuring acetabular angle of anteversion.
Time frame: 6 months post-op
Integrity of the periarticular muscles.
MRI examination. Grading based on the Goutallier classification.
Time frame: 6 months post-op
Oxford Hip Score
Joint-specific patient-reported outcome measure of disability in patients following THA
Time frame: 3- and 6-months post-op
UCLA Activity Score
Validated 10-point scale evaluating patient activity levels
Time frame: 3- and 6-months post-op
VR-12
Patient-reported outcome measure of patient's overall perspective of their health
Time frame: 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.
Time frame: 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)
Time frame: 3- and 6-months post-op
Harris Hip Score
A measure of dysfunction following total hip arthroplasty
Time frame: 3- and 6-months post-op
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