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OpenTrials
Completed

NCT Number: NCT02808169

Radlink 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.

Completed

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Key information

Conditions

Implant Position in Total Hip Replacement

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VOA Research Foundation

Renton, Washington, 98055, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 4-8 weeks

Secondary outcomes

  1. Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.

    Time frame: 4-8 weeks

Sponsors and collaborators

Lead sponsor

Barrett, William, M.D.

Indiv

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2016
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.