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

NCT ID: NCT05416463

Last Updated: 2022-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

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

Group Type SHAM_COMPARATOR

Intra-Operative Device for THA

Intervention Type PROCEDURE

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

Treatment

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

Group Type EXPERIMENTAL

Intra-Operative Device for THA

Intervention Type PROCEDURE

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

Interventions

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Intra-Operative Device for THA

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)\*
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grand River Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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INSTHA

Identifier Type: -

Identifier Source: org_study_id

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