Total Hip Arthroplasty
Conditions
Brief summary
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.
Interventions
PROCEDUREIntra-Operative Device for THA
The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.
Sponsors
Grand River Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Receiving primary THA * Elective THA * Provision of informed consent
Exclusion criteria
* Unable to obtain informed consent * Receiving revision THA * THA is to treat trauma (i.e. hip fracture and/or dislocation) * Patient is undergoing simultaneous bilateral hip replacement * Performing surgeon is not participating in the study * Hip fracture * Hip dislocation * Severe osteoporosis * Trochanteric osteotomy * Suspected or actual infection * Existing implanted hardware * Severe deformities of the femoral or pelvic bone * High Body Mass Index (BMI)\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activities of Daily Living | up to 12 months | Hip disability and Osteoarthritis Outcome Score (HOOS) Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a HOOS profile. 0 indicates extreme problems and 100 indicates no problems. |
Outcome results
None listed