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

Not Applicable

Not yet recruiting

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Intra-Operative Device for THA

• Registration Number: NCT05416463
• Lead Sponsor: Grand River Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13
• Study Start: 2022-07
• Primary Completion: 2023-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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."