Pre-Op THA Modelling

Not Applicable

Recruiting

• Conditions: Total Hip Arthroplasty; Computer-Assisted Surgery
• Interventions: Procedure: Computer-navigated THA surgery; Procedure: Standard of care THA surgery

• Registration Number: NCT05221554
• Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-03
• Study Start: 2022-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Computer-Navigated Cohort	Computer-navigated THA surgery	Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.
Cross-sectional Standard of Care Cohort	Standard of care THA surgery	Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.

Primary Outcome Measures

Name	Time	Method
Muscle area	6 months post-op	CT examination measuring muscle cross-sectional area (in mm2).
Quantification of fluid.	6 months post-op	MRI examination. Grading according to Mitchel et al. 1986
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.
Degree of heterotopic ossification	6 months post-op	CT examination. Classification of heterotopic ossification based on Brooker Classification.
Muscle density	6 months post-op	CT examination measuring radiological density (in HU).
Integrity of the periarticular muscles.	6 months post-op	MRI examination. Grading based on the Goutallier classification.
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.
Joint effusion.	6 months post-op	MRI examination. Grading according to Mitchel et al. 1986
Capsular scarring	6 months post-op	MRI examination. Measuring the joint capsule in its thickest part.
Heterotopic ossification in periarticular soft tissues.	6 months post-op	MRI examination. Classification of heterotopic ossification based on Brooker Classification.

Secondary Outcome Measures

Name	Time	Method
VR-12	3- and 6-months post-op	Patient-reported outcome measure of patient's overall perspective of their health
Oxford Hip Score	3- and 6-months post-op	Joint-specific patient-reported outcome measure of disability in patients following THA
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.
UCLA Activity Score	3- and 6-months post-op	Validated 10-point scale evaluating patient activity levels
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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada