Purpose of this Study
If you join this study, you will have the surgery your doctor planned. You can choose to use the regular tool or be randomly picked to use either the regular tool or a new one. Blood will be taken three times (before, during, and after surgery). Doctors will also check your regular cancer visits for one year. The study does not add extra visits or tests.
Who Can Participate?
Eligibility
Adults 18 and older may join this study if their cancer started in another part of the body, like the breast or lung, and spread to the thigh bone. Their thigh bone must be weak and at risk of breaking, and their doctor must recommend putting in a metal rod. People cannot join if they are under 18, have bone cancer, already broke their thigh bone, or do not need the rod.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a special tool called RIA to see if it releases fewer cancer cells into the blood during bone surgery. The RIA washes and suctions while it drills, which may help keep pressure lower in the bone. Doctors will count cancer cells during surgery and watch how the cancer acts over the next year to see if the RIA makes surgery safer.
Locations
Duke University Hospital
Visit Timing
Weekdays
Evenings
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Does the use of the reamer-irrigator-aspirator (RIA) during prophylactic intramedullary nailing attenuate the rise of circulating tumor cells?
Study Website
Principal Investigator
William
Eward
Protocol Number
PRO00110727
NCT ID
NA
Phase
N/A
Enrollment Status
Open to Enrollment