Pre-Op THA Modelling

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221554
• Other study ID #: 11307
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Lawson Health Research Institute
• Contact: Brent Lanting
• Phone: 519-663-3335
• Email: Brent.Lanting[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Computer-Assisted Surgery
• Total Hip Arthroplasty

Intervention

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.
• Standard of care THA surgery
Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular cup position	CT examination. Measuring acetabular cup inclination and anteversion in degrees.	6 months post-op
Primary	Protrusion length	CT examination. Length of protrusion in the sagittal and axial view.	6 months post-op
Primary	Acetabular cup loosening	CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency > 2 mm in width.	6 months post-op
Primary	Degree of heterotopic ossification	CT examination. Classification of heterotopic ossification based on Brooker Classification.	6 months post-op
Primary	Muscle area	CT examination measuring muscle cross-sectional area (in mm2).	6 months post-op
Primary	Muscle density	CT examination measuring radiological density (in HU).	6 months post-op
Primary	Capsular scarring	MRI examination. Measuring the joint capsule in its thickest part.	6 months post-op
Primary	Joint effusion.	MRI examination. Grading according to Mitchel et al. 1986	6 months post-op
Primary	Quantification of fluid.	MRI examination. Grading according to Mitchel et al. 1986	6 months post-op
Primary	Heterotopic ossification in periarticular soft tissues.	MRI examination. Classification of heterotopic ossification based on Brooker Classification.	6 months post-op
Primary	Soft tissue impingement	MRI examination. Measuring acetabular angle of anteversion.	6 months post-op
Primary	Integrity of the periarticular muscles.	MRI examination. Grading based on the Goutallier classification.	6 months post-op
Secondary	Oxford Hip Score	Joint-specific patient-reported outcome measure of disability in patients following THA	3- and 6-months post-op
Secondary	UCLA Activity Score	Validated 10-point scale evaluating patient activity levels	3- and 6-months post-op
Secondary	VR-12	Patient-reported outcome measure of patient's overall perspective of their health	3- and 6-months post-op
Secondary	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
Secondary	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
Secondary	Harris Hip Score	A measure of dysfunction following total hip arthroplasty	3- and 6-months post-op