Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty

NCT04101864 | Completed

• 1 other identifier: 77/05/12
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis

Keywords

navigation; hip arthroplasty; surgical time; landmark

Outcome Measures

Primary Outcomes (1)

• Acetabular component position

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

  Up to 48 hours after surgery

Secondary Outcomes (2)

• Surgical time

  Immediately after surgical procedure

• Clinical result

  8-10 weeks postoperatively

Study Arms (2)

Electromagnetic navigation

EXPERIMENTAL

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.

Procedure: Electromagnetic navigation

Freehand

ACTIVE COMPARATOR

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

Procedure: Freehand

Interventions

Electromagnetic navigation PROCEDURE

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

Electromagnetic navigation

Freehand PROCEDURE

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

Freehand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Valdoltra Orthopedic Hospital: lead

Study Sites (1)

Valdoltra Orthopedic Hospital

Ankaran, 6280, Slovenia

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rene Mihalič, MD

  Valdoltra Orthopedic Hospital

  PRINCIPAL INVESTIGATOR

• Rihard Trebše, MD, PhD

  Valdoltra Orthopedic Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative computed tomography measurements of acetabular component position will be done by independent technician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sample size will be calculated. The Consolidated Standards of Reporting Trials statement guidelines will be followed to perform this prospective, randomized, controlled, trial and to present the results. Included patients will be randomly allocated in a 1:1 ratio into the study and the control group. Randomization will be conducted using computer-generated numbers.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 24, 2019
• Study Start: May 4, 2017
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)