An observational study in Osteoarthritis, sponsored by Kirill Gromov. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Kirill Gromov · Observational
The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. The investigators will further evaluate safety aspects, such a early morbidity and mortality, as well as patient satisfaction.
Fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and Unicompartmental Knee arthroplasty (UKA) with length of stay (LOS) of 1-3 is a well established concept for treating hip and knee osteoarthritis, resulting in short reconvalescence, high patient satisfaction, and an excellent safety profile (lower or similar mortality / morbidity compared to conventional pathways with longer LOS). LOS have been significantly reduced during the past decade, and several centers have published even shorter hospitals stays: \<24 hours, with patients staying the night at the hospital but also outpatient surgery, with patients being discharged on the day of surgery.
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
Safety
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 1,000 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Kirill Gromov as lead sponsor.
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Exclusion Criteria:
* 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)
Other: Does fulfil of discharge criteria on the day of the surgery · Other: Does not fulfil of discharge criteria on the day of the surgery
* 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)
Other: Does fulfil of discharge criteria on the day of the surgery · Other: Does not fulfil of discharge criteria on the day of the surgery
* 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)
Other: Does fulfil of discharge criteria on the day of the surgery · Other: Does not fulfil of discharge criteria on the day of the surgery
Fulfilment of same day discharge criteria
On the days of surgery following discharge criteria are continuously evaluated: * \< 500 ml intraoperative blood loss * Back in patient ward \<15.00 * Received instruction from physiotherapist and is safely mobilized * No clinical symptoms of anemia * Pain \<3 while resting, \<5 during exercise. * Spontaneous urination * Post op x-ray is performed and approved * Relatives or friends with patient for \>24 hours * Motivated and accepts same day discharge * Standard discharge criteria fulfilled * Can be discharged before 20.00 If all of the above criteria are fulfilled, the patient can be discharged
Time frame: 12 hours
Readmissions
Time frame: 3 months
Patient reported satisfaction
OKS (Oxford Knee score) and ROM (Range og motion) for TKA and UKA, OHS for THA
Time frame: 3 months
Use of rescue morphine
Time frame: 7 days
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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