Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software

Sponsor

Anderson Orthopaedic Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02536573

Collaborator

(none)

200

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Replacement	Other: Radlink Surgical Positioning Software	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Apr 11, 2017

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Radiographic cup abduction angle [4 month postoperative]
Angle of acetabular component in coronal plane measured on x-ray
Radiographic cup anteversion angle [4 month postoperative]
Angle of acetabular component in sagittal plane measured on x-ray

Secondary Outcome Measures

Variance of cup angles measured on x-ray [4 month postoperative]
Statistical homogeneity of angles and how spread out the data is.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Total hip arthroplasty

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Anderson Orthopaedic Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anderson Orthopaedic Research Institute

ClinicalTrials.gov Identifier:

NCT02536573

Other Study ID Numbers:

AORI 2015-0101

First Posted:

Sep 1, 2015

Last Update Posted:

Aug 1, 2019

Last Verified:

Jul 1, 2019

Keywords provided by Anderson Orthopaedic Research Institute

Total hip replacement

Study Results

No Results Posted as of Aug 1, 2019