Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software

July 30, 2019 updated by: Anderson Orthopaedic Research Institute

Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software

This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total hip arthroplasty

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments.
Experimental: Radlink Surgical Positioning System
Fluoroscopic image of the hip joint is imported into the Radlink Surgical Positioning software. The software calculates a target cup position using bony landmarks, and the surgeon matches the cup to the target.
Other: Radlink Surgical Positioning Software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic cup abduction angle
Time Frame: 4 month postoperative
Angle of acetabular component in coronal plane measured on x-ray
4 month postoperative
Radiographic cup anteversion angle
Time Frame: 4 month postoperative
Angle of acetabular component in sagittal plane measured on x-ray
4 month postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variance of cup angles measured on x-ray
Time Frame: 4 month postoperative
Statistical homogeneity of angles and how spread out the data is.
4 month postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anderson Orthopaedic Research Institute

Investigators

  • Principal Investigator: William G Hamilton, MD, AORI (Anderson Orthopaedic Research Institute)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

April 11, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AORI 2015-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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