Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01858051
Status:
WITHDRAWN
Last Update Posted:
2017-03-30
First Post:
2013-05-16
Brief Title:
Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Bolus vs Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the United States 1 million elective hip or knee replacement surgeries are performed annually With estimated surgical site infection SSI rates as high as 25 this represents 25000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery Although SSIs only account for 20 of all HAIs they are a major risk factor for prosthetic joint infections PJIs Furthermore UTIs have also been identified as an independent risk factor for infections of implanted hardware
In general the majority of PJIs become apparent within 3 months of hardware implantation but deep infections may not be evident for up to one year after surgery Hardware infections result in delayed healing repeated surgical interventions and long-term antibiotic therapy PJIs are associated with an average increase in hospital LOS by 14 days additional expenditures of up to 50000 per infected joint and a doubling of the mortality rate compared to uninfected lower extremity joint replacements
Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs The prevalence of vitamin D insufficiency is approximately 40 in elective joint replacement surgery patients and perioperative 25OHD levels drop 30-40 in the setting of surgical stress remaining 20 below baseline up to 3 months after surgery To date perioperative vitamin D optimization strategies have not been reported Therefore our goal is to study the effect of a single pre-operative versus a divided pre-operative and on post-operative day 1 dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery
In general the majority of PJIs become apparent within 3 months of hardware implantation but deep infections may not be evident for up to one year after surgery Hardware infections result in delayed healing repeated surgical interventions and long-term antibiotic therapy PJIs are associated with an average increase in hospital LOS by 14 days additional expenditures of up to 50000 per infected joint and a doubling of the mortality rate compared to uninfected lower extremity joint replacements
Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs The prevalence of vitamin D insufficiency is approximately 40 in elective joint replacement surgery patients and perioperative 25OHD levels drop 30-40 in the setting of surgical stress remaining 20 below baseline up to 3 months after surgery To date perioperative vitamin D optimization strategies have not been reported Therefore our goal is to study the effect of a single pre-operative versus a divided pre-operative and on post-operative day 1 dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None