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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Intra-Operative Device for THA

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)*

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; The control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery	Procedure: Intra-Operative Device for THA; The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.
Experimental: Treatment; The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.	Procedure: Intra-Operative Device for THA; The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Grand River Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: INSTHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No