Radlink GPS Provide a Valid Intra-operative Assessment of... | NCT02808169

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

NCT02808169

Sponsor

Barrett, William, M.D.

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Implant Position in Total Hip Replacement

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2015Actual

Primary Completion Date

Aug 8, 2016Actual

Completion Date

Aug 8, 2016Actual

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jun 17, 2016

First Posted Date

Jun 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2017

Last Update Posted Date

Jul 21, 2017Actual

Name	Class
DePuy Synthes	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patient under going total hip replacement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Barrett, MD	VOA Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VOA Research Foundation		Renton	Washington	98055	United States