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

NCT ID: NCT02808169

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-20

Study Completion Date

2016-08-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Implant Position in Total Hip Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DePuy Synthes

INDUSTRY

Sponsor Role collaborator

Barrett, William, M.D.

INDIV

Sponsor Role lead

Responsible Party

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William Barrett, M.D.

William P. Barrett, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

VOA Research Foundation

Locations

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VOA Research Foundation

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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20151031

Identifier Type: -

Identifier Source: org_study_id

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