Pre-Op THA Modelling

NCT05221554 | Recruiting

• 1 other identifier: 11307
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty; Computer-Assisted Surgery

Keywords

Osteoarthritis; Joint Disease; Musculoskeletal Disease

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Oxford Hip Score

  3- and 6-months post-op

• UCLA Activity Score

  3- and 6-months post-op

• VR-12

  3- and 6-months post-op

• WOMAC questionnaire

  3- and 6-months post-op

• Novel questionnaire

  3- and 6-months post-op

Study Arms (2)

Prospective Computer-Navigated Cohort

EXPERIMENTAL

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

Cross-sectional Standard of Care Cohort

ACTIVE COMPARATOR

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

Interventions

Computer-navigated THA surgery PROCEDURE

Navigation software coupled with real-time modeling software will be used to plan optimal acetabular cup for patients undergoing THA.

Prospective Computer-Navigated Cohort

Standard of care THA surgery PROCEDURE

Patients already underwent THA procedure with manual placement of acetabular cup with conventional instrumentation.

Cross-sectional Standard of Care Cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• osteoarthritis of the hip requiring primary THA
• years of age or older
• BMI \<40 kg/m2
• able to provide informed consent, able and willing to do study assessments and follow instructions

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Study Officials

• Brent Lanting

  London Health Sciences Centre/Lawson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Lanting

CONTACT

519-663-3335; Brent.Lanting@lhsc.on.ca

Lyndsay Somerville

CONTACT

519-685-8500; Lyndsay.Somerville@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: February 3, 2022
• Study Start: August 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)