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

Grand River Hospital

Status: Not yet enrolling

Conditions: Total Hip Arthroplasty

Treatments: Procedure: Intra-Operative Device for THA

Study type: Interventional

Funder types: Other

Identifiers

NCT05416463

INSTHA

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

190 participants in 2 patient groups

Control

Sham Comparator group

Description:

The control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery

Treatment:

Procedure: Intra-Operative Device for THA

Treatment

Experimental group

Description:

The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.

Treatment:

Procedure: Intra-Operative Device for THA