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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Imageless computer-navigated THA surgery
Procedure/SurgeryNavigation 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/SurgeryPatients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.
CT-based Computer-navigated THA surgery
Procedure/SurgeryCT- based computer navigation software coupled with modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
Treatment groups
Trial outcomes
Primary outcomes
Acetabular cup position
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
Protrusion length
CT examination. Length of protrusion in the sagittal and axial view.
Acetabular cup loosening
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency \> 2 mm in width.
Degree of heterotopic ossification
CT examination. Classification of heterotopic ossification based on Brooker Classification.
Secondary outcomes
Oxford Hip Score
Joint-specific patient-reported outcome measure of disability in patients following THA
UCLA Activity Score
Validated 10-point scale evaluating patient activity levels
VR-12
Patient-reported outcome measure of patient's overall perspective of their health
WOMAC questionnaire
Self-administered questionnaire assessing activities of daily living, functional mobility, gait, general health and quality of life.
Sponsors and contacts
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