INSTHA: Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

• Sponsor: Grand River Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05416463
• Collaborator: (none)
• Enrollment: 190
• Arms: 2
• Anticipated Duration (Months): 29

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Procedure: Intra-Operative Device for THA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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)*

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Grand River Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grand River Hospital
• ClinicalTrials.gov Identifier: NCT05416463
• Other Study ID Numbers: INSTHA
• First Posted: Jun 13, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

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

Study Results

No Results Posted as of Jun 13, 2022