Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
INSTHA
A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
1 other identifier
interventional
190
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 13, 2022
June 1, 2022
11 months
June 7, 2022
June 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Activities of Daily Living
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."
up to 12 months
Study Arms (2)
Control
SHAM COMPARATORThe control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery
Treatment
EXPERIMENTALThe intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.
Interventions
The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.
Eligibility Criteria
You may qualify if:
- Receiving primary THA
- Elective THA
- Provision of informed consent
You may not qualify if:
- 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)\*
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 13, 2022
Study Start
July 1, 2022
Primary Completion
June 1, 2023
Study Completion
December 1, 2024
Last Updated
June 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share