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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02808169

Enrollment

200

Registered

2016-06-21

Start date

2015-11-20

Completion date

2016-08-08

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Position in Total Hip Replacement

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results