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Clinical Trials/NCT05221554
NCT05221554
Recruiting
N/A

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

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrollment
80
Locations
1
Primary Endpoint
Muscle area
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
November 30, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brent Lanting

Principal Investigator

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Muscle area

Time Frame: 6 months post-op

CT examination measuring muscle cross-sectional area (in mm2).

Quantification of fluid.

Time Frame: 6 months post-op

MRI examination. Grading according to Mitchel et al. 1986

Soft tissue impingement

Time Frame: 6 months post-op

MRI examination. Measuring acetabular angle of anteversion.

Acetabular cup position

Time Frame: 6 months post-op

CT examination. Measuring acetabular cup inclination and anteversion in degrees.

Degree of heterotopic ossification

Time Frame: 6 months post-op

CT examination. Classification of heterotopic ossification based on Brooker Classification.

Muscle density

Time Frame: 6 months post-op

CT examination measuring radiological density (in HU).

Integrity of the periarticular muscles.

Time Frame: 6 months post-op

MRI examination. Grading based on the Goutallier classification.

Protrusion length

Time Frame: 6 months post-op

CT examination. Length of protrusion in the sagittal and axial view.

Acetabular cup loosening

Time Frame: 6 months post-op

CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency \> 2 mm in width.

Joint effusion.

Time Frame: 6 months post-op

MRI examination. Grading according to Mitchel et al. 1986

Capsular scarring

Time Frame: 6 months post-op

MRI examination. Measuring the joint capsule in its thickest part.

Heterotopic ossification in periarticular soft tissues.

Time Frame: 6 months post-op

MRI examination. Classification of heterotopic ossification based on Brooker Classification.

Secondary Outcomes

  • VR-12(3- and 6-months post-op)
  • Oxford Hip Score(3- and 6-months post-op)
  • WOMAC questionnaire(3- and 6-months post-op)
  • UCLA Activity Score(3- and 6-months post-op)
  • Novel questionnaire(3- and 6-months post-op)
  • Harris Hip Score(3- and 6-months post-op)

Study Sites (1)

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