Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

Valdoltra Orthopedic Hospital

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Procedure: Electromagnetic navigation; Procedure: Freehand

Study type: Interventional

Funder types: Other

Identifiers

NCT04101864

77/05/12

Details and patient eligibility

About

A prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.

Full description

Patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. Patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. Patients allocated to the control group will get their acetabular components implanted with freehand technique. Accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. Postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. Results will be statistically analyzed and compared.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age above 18 years
• unilateral surgery
• osteoarthritis of the hip
• no previous surgery on the affected hip
• implantation of the same acetabular component through the same approach
• signed informed consent

Exclusion criteria

• age under 18 years
• unwilling to participate
• prior surgery on affected hip

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Electromagnetic navigation

Experimental group

Description:

In the study group acetabular components in total hip arthroplasty will be placed with the help of electromagnetic image-less navigation system. Reference plane will be anterior pelvic plane.

Treatment:

Procedure: Electromagnetic navigation

Freehand

Active Comparator group

Description:

In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.

Treatment:

Procedure: Freehand