Pre-Op THA Modelling

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status: Enrolling

Conditions: Total Hip Arthroplasty; Computer-Assisted Surgery

Treatments: Procedure: Standard of care THA surgery; Procedure: Computer-navigated THA surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05221554

11307

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Prospective Computer-Navigated Cohort

Experimental group

Description:

Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.

Treatment:

Procedure: Computer-navigated THA surgery

Cross-sectional Standard of Care Cohort

Active Comparator group

Description:

Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.

Treatment:

Procedure: Standard of care THA surgery