Pre-Op THA Modelling

Pre-Op Total Hip Arthroplasty Modelling: Individualized Care, Improved Outcomes

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 Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty; Computer-Assisted Surgery
• Intervention / Treatment: Procedure: Computer-navigated THA surgery; Procedure: Standard of care THA surgery

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Recruiting
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective Computer-Navigated Cohort; Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.	Procedure: Computer-navigated THA surgery; Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.
Active Comparator: Cross-sectional Standard of Care Cohort; Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.	Procedure: Standard of care THA surgery; Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular cup position	CT examination. Measuring acetabular cup inclination and anteversion in degrees.	6 months post-op
Protrusion length	CT examination. Length of protrusion in the sagittal and axial view.	6 months post-op
Acetabular cup loosening	CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.	6 months post-op
Degree of heterotopic ossification	CT examination. Classification of heterotopic ossification based on Brooker Classification.	6 months post-op
Muscle area	CT examination measuring muscle cross-sectional area (in mm2).	6 months post-op
Muscle density	CT examination measuring radiological density (in HU).	6 months post-op
Capsular scarring	MRI examination. Measuring the joint capsule in its thickest part.	6 months post-op
Joint effusion.	MRI examination. Grading according to Mitchel et al. 1986	6 months post-op
Quantification of fluid.	MRI examination. Grading according to Mitchel et al. 1986	6 months post-op
Heterotopic ossification in periarticular soft tissues.	MRI examination. Classification of heterotopic ossification based on Brooker Classification.	6 months post-op
Soft tissue impingement	MRI examination. Measuring acetabular angle of anteversion.	6 months post-op
Integrity of the periarticular muscles.	MRI examination. Grading based on the Goutallier classification.	6 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Hip Score	Joint-specific patient-reported outcome measure of disability in patients following THA	3- and 6-months post-op
UCLA Activity Score	Validated 10-point scale evaluating patient activity levels	3- and 6-months post-op
VR-12	Patient-reported outcome measure of patient's overall perspective of their health	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.	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)	3- and 6-months post-op
Harris Hip Score	A measure of dysfunction following total hip arthroplasty	3- and 6-months post-op

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Joint Disease; Musculoskeletal Disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: 11307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No