Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)
NCT ID: NCT04195360
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
42 participants
OBSERVATIONAL
2019-12-02
2020-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Orthostatic intolerant (OI)
Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilization
Standardized mobilization procedure
5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)
Orthostatic tolerant (OT)
Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilization
Standardized mobilization procedure
5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)
Interventions
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Standardized mobilization procedure
5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
* Patients that speak and understand Danish
* Written informed consent
Exclusion Criteria
* Alcohol or substance abuse
* everyday treatment with either anxiolytic or antipsychotic medicine
* Cognitive dysfunction
* If surgery was converted to general anesthesia or total knee arthroplasty.
18 Years
ALL
No
Sponsors
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Kehlet, Henrik, M.D., Ph.D.
INDIV
Copenhagen University Hospital, Hvidovre
OTHER
Responsible Party
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Louise Bundsgaard Andersen
Undergraduate Student
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Central Contacts
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Louise Bundsgaard Andersen, medical student
Role: CONTACT
Phone: +45 41161599
Email: [email protected]
Facility Contacts
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Louise Bundsgaard Andersen, Medical student
Role: primary
References
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Hristovska AM, Andersen LB, Uldall-Hansen B, Kehlet H, Troelsen A, Gromov K, Foss NB. Postoperative orthostatic intolerance following fast-track unicompartmental knee arthroplasty: incidence and hemodynamics-a prospective observational cohort study. J Orthop Surg Res. 2024 Apr 1;19(1):214. doi: 10.1186/s13018-024-04639-6.
Other Identifiers
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H-19063289
Identifier Type: -
Identifier Source: org_study_id