NCT02536573

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

August 24, 2015

Last Update Submit

July 30, 2019

Conditions

Total Hip Replacement

Keywords

Total hip replacement

Outcome Measures

Primary Outcomes (2)

  • Radiographic cup abduction angle

    Angle of acetabular component in coronal plane measured on x-ray

    4 month postoperative

  • Radiographic cup anteversion angle

    Angle of acetabular component in sagittal plane measured on x-ray

    4 month postoperative

Secondary Outcomes (1)

  • Variance of cup angles measured on x-ray

    4 month postoperative

Study Arms (2)

Control

NO INTERVENTION

Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments.

Radlink Surgical Positioning System

EXPERIMENTAL

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

Interventions

Radlink Surgical Positioning SoftwareOTHER
Radlink Surgical Positioning System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total hip arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • William G Hamilton, MD

    AORI (Anderson Orthopaedic Research Institute)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 1, 2015

Study Start

December 1, 2015

Primary Completion

April 11, 2017

Study Completion

April 1, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07