Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion

Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion

Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

Study Overview

• Status: Completed
• Conditions: Implant Position in Total Hip Replacement

Detailed Description

Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98055
      • VOA Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient under going total hip replacement

Description

Inclusion Criteria:

• Both: both female and male participants are being studied.
• Minimum Age: Age of participants is between 20 years - 75 years.
• Accepts: Persons who are in need of a total hip replacement

Exclusion Critieria:

• Has an existing condition that would compromise participation
• Had previous surgery on affected hip

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.	4-8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.	4-8 weeks

Collaborators and Investigators

• Sponsor: Barrett, William, M.D.
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: William Barrett, MD, VOA Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2015
• Primary Completion (Actual): August 8, 2016
• Study Completion (Actual): August 8, 2016

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 20151031