Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-06 @ 11:13 PM
Study NCT ID:
NCT04195360
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)
Sponsor:
Copenhagen University Hospital, Hvidovre
Organization:
Study Overview
Official Title:
Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
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:
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA
Detailed Description:
In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) \> 20 mmHg or a drop \>10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.
Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.
This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.
Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.
This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: