Recruiting

Computer Navigation

Sponsor:

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

Code:

NCT05221554

Conditions

Total Hip Arthroplasty

Computer-Assisted Surgery

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Computer-navigated THA surgery

Standard of care THA surgery

Study Details

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

Study ID

NCT05221554

Start date

Aug 1, 2022

Status verified date

May, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Acetabular cup position [ Time Frame: 6 months post-op ]
  • Protrusion length [ Time Frame: 6 months post-op ]
  • Acetabular cup loosening [ Time Frame: 6 months post-op ]
  • Degree of heterotopic ossification [ Time Frame: 6 months post-op ]
  • Muscle area [ Time Frame: 6 months post-op ]
  • Muscle density [ Time Frame: 6 months post-op ]
  • Capsular scarring [ Time Frame: 6 months post-op ]
  • Joint effusion. [ Time Frame: 6 months post-op ]
  • Quantification of fluid. [ Time Frame: 6 months post-op ]
  • Heterotopic ossification in periarticular soft tissues. [ Time Frame: 6 months post-op ]
  • Soft tissue impingement [ Time Frame: 6 months post-op ]
  • Integrity of the periarticular muscles. [ Time Frame: 6 months post-op ]

Central Contacts and Locations

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Lyndsay Somerville, PhD

lyndsay.somerville@lhsc.on.ca

Principal Investigator:

Brent Lanting

More Information

Sponsor

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

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Osteoarthritis
  • Joint Disease
  • Musculoskeletal Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-05-13.