Clinical trial NCT05221554: Pre-Op THA Modelling
Official title: Pre-Op Total Hip Arthroplasty Modelling: Individualized Care, Improved Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Computer-Assisted Surgery
Keywords: Osteoarthritis
Joint Disease
Musculoskeletal Disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Acetabular cup position
timeFrame: 6 months post-op
measure: Protrusion length
timeFrame: 6 months post-op
measure: Acetabular cup loosening
timeFrame: 6 months post-op
measure: Degree of heterotopic ossification
timeFrame: 6 months post-op
measure: Muscle area
timeFrame: 6 months post-op
measure: Muscle density
timeFrame: 6 months post-op
measure: Capsular scarring
timeFrame: 6 months post-op
measure: Joint effusion.
timeFrame: 6 months post-op
measure: Quantification of fluid.
timeFrame: 6 months post-op
measure: Heterotopic ossification in periarticular soft tissues.
timeFrame: 6 months post-op
measure: Soft tissue impingement
timeFrame: 6 months post-op
measure: Integrity of the periarticular muscles.
timeFrame: 6 months post-op
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: 3- and 6-months post-op
measure: UCLA Activity Score
timeFrame: 3- and 6-months post-op
measure: VR-12
timeFrame: 3- and 6-months post-op
measure: WOMAC questionnaire
timeFrame: 3- and 6-months post-op
measure: Novel questionnaire
timeFrame: 3- and 6-months post-op
measure: Harris Hip Score
timeFrame: 3- and 6-months post-op
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre/Lawson
name: Brent Lanting
role: PRINCIPAL_INVESTIGATOR
References: