NCT02808169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

June 17, 2016

Last Update Submit

July 20, 2017

Conditions

Implant Position in Total Hip Replacement

Outcome Measures

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.

    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.

    4-8 weeks

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient under going total hip replacement

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VOA Research Foundation

Renton, Washington, 98055, United States

Location

Study Officials

  • William Barrett, MD

    VOA Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
William P. Barrett, MD

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

November 20, 2015

Primary Completion

August 8, 2016

Study Completion

August 8, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)