Computer-Assisted Surgery, Total Hip Arthroplasty
Conditions
Keywords
Osteoarthritis, Joint Disease, Musculoskeletal Disease
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.
Interventions
PROCEDUREComputer-navigated THA surgery
Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
PROCEDUREStandard of care THA surgery
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrity of the periarticular muscles. | 6 months post-op | MRI examination. Grading based on the Goutallier classification. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Oxford Hip Score | 3- and 6-months post-op | Joint-specific patient-reported outcome measure of disability in patients following THA |
Countries
Canada
Contacts
Primary ContactBrent Lanting
Backup ContactLyndsay Somerville
Outcome results
None listed