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Recruiting NCT05221554

Pre-Op THA Modelling

No phase Interventional Total Hip Arthroplasty Computer-Assisted Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer-navigated THA surgery, Standard of care THA surgery.
Who it may be relevant to
Registry conditions: Total Hip Arthroplasty, Computer-Assisted Surgery. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Oxford Hip Score [Time frame: 3- and 6-months post-op]
  • UCLA Activity Score [Time frame: 3- and 6-months post-op]
  • VR-12 [Time frame: 3- and 6-months post-op]
  • WOMAC questionnaire [Time frame: 3- and 6-months post-op]
  • Novel questionnaire [Time frame: 3- and 6-months post-op]
  • Harris Hip Score [Time frame: 3- and 6-months post-op]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT05221554 · 11307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗