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NCT Number: NCT04101864

Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valdoltra Orthopedic Hospital

Ankaran, 6280, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromagnetic navigation

Procedure

Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.

Freehand

Procedure

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

Primary outcomes

  1. Acetabular component position

    Time frame: Up to 48 hours after surgery

    Comparison of the precision and the accuracy of acetabular components between both groups

Secondary outcomes

  1. Surgical time

    Time frame: Immediately after surgical procedure

    Comparison of duration of surgery between both groups

  2. Clinical result

    Time frame: 8-10 weeks postoperatively

    Comparison of improvement of Harris hip score between both groups

Sponsors and collaborators

Lead sponsor

Valdoltra Orthopedic Hospital

Other

Registry information

Official study title

Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 24, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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