Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study
NCT ID: NCT02544620
Last Updated: 2019-03-28
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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COMPLETED
1000 participants
OBSERVATIONAL
2015-09-30
2018-12-31
Brief Summary
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Detailed Description
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However, these proposed pathways with extremely short LOS, are performed on very selected patients, with few details on patient satisfaction, outcome and most important patient safety. Therefore, it is not possible to draw conclusions on feasibility of outpatient THA, TKA and UKA surgery in a general and unselected population. Further on, there is a need for investigation of safety aspects of outpatient surgery in respect to mortality, morbidity, patient satisfaction and patient reported outcomes. As some, most likely healthy and younger, patients might benefit from outpatient surgery - eg discharge on the day of surgery, while others might not; the first step is to identify the patients that are suitable for outpatient THA and TKA surgery and investigate the safety aspects in respect to mortality, morbidity, patient satisfaction and patient reported outcomes.
Aim:
The aim of this study is to investigate "feasibility" and "safety" of outpatient THA, TKA and UKA surgery, respectively as follows:
Feasibility
* Proportion of patients, that can be included in the study according to inclusion criteria stated below, and be evaluated for potential same-day discharge (I) (I = included)
* Proportion of included patients (I), that are discharged on the day of surgery (U) and those who are not discharged and stay for \>1 day (B)
* Identify reasons for patients not being able to be discharged on the day of surgery (B)
Safety
* risk for complications (morbidity) in group (U) compared to group (B) (are there complications that potentially could have been avoided is the patient was not discharged)
* readmissions in group (U ) compared to group (B) within 90 days
* mortality in group (U ) compared to group (B) within 90 days
* patient satisfaction in group (U ) compared to group (B)
* Patient reported outcome (Oxford knee score + range of motion for TKA and UKA group, and Oxford hip score for THA group) in group (U) compared to group (B)
* contacts to primary sector in group (U ) compared to group (B) within 7 days.
* use of rescue morphine (pain journal) for 7 days post op in group (U ) compared to group (B)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total Hip arthroplasty
* Unselected primary THA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP)
Does fulfil of discharge criteria on the day of the surgery
Does not fulfil of discharge criteria on the day of the surgery
Total Knee arthroplasty
* Unselected primary TKA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP)
Does fulfil of discharge criteria on the day of the surgery
Does not fulfil of discharge criteria on the day of the surgery
unicompartmental knee arthroplasty
* Unselected primary UKA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP)
Does fulfil of discharge criteria on the day of the surgery
Does not fulfil of discharge criteria on the day of the surgery
Interventions
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Does fulfil of discharge criteria on the day of the surgery
Does not fulfil of discharge criteria on the day of the surgery
Eligibility Criteria
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Inclusion Criteria
* ASA score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with CPAP
Exclusion Criteria
* ASA score \> 2
* Cannot be operated as #1 or #2
* Sleep apnea treated with CPAP
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Vejle Hospital
OTHER
Holsterbro Sygehus, DK
UNKNOWN
Kirill Gromov
OTHER
Responsible Party
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Kirill Gromov
MD, PhD
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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HVH-SK-TKA-THA-UKA
Identifier Type: -
Identifier Source: org_study_id
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