Length of Stay Clinical Trial
Official title:
Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial
The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.
Status | Recruiting |
Enrollment | 312 |
Est. completion date | January 24, 2025 |
Est. primary completion date | January 24, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Candidates for ambulatory total knee arthroplasty - Candidates for ambulatory total hip arthroplasty - Candidates for ambulatory revision knee arthroplasty (liner exchange only) - Candidates for ambulatory revision hip arthroplasty (liner exchange only) - Case scheduled before noon (12 pm) - Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge Exclusion Criteria: - BMI less than 18.5 or greater than 37.0 - Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb. - Pregnant women - Patients scheduled as ambulatory due to insurance mandates - Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate < 60ml/min. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospital stay in hours | Length of hospital stay in hours, assess by medical record. | From admission to discharge, up to 1 week | |
Secondary | Same day discharge rate | Percentage of patients discharged successfully the day of surgery. | Through study completion, an average of 3 months. | |
Secondary | Number of physical therapy sessions attempted | Number of physical therapy sessions attempted, assess by medical record. | From admission to discharge, up to 1 week. | |
Secondary | Total distance walked | Total distance walked during physical therapy attempts, assess by medical record. | From admission to discharge, up to 1 week. | |
Secondary | Number of stairs climbed | Number of stairs climbed during physical therapy attempts, assess by medical record. | From admission to discharge, up to 1 week. | |
Secondary | Orthostatic hypotension episodes | Orthostatic hypotension episodes during physical therapy attempts, assess by medical record. | During physical therapy attempts, from admission to discharge. | |
Secondary | HOOS JR Score | This is a 6-item questionnaire that assesses patient-reported hip pain and function. Score ranges from 0-100, with 100 representing the best possible score. | The morning of surgery and at the first post-operative visit, up to 4 months post-op. | |
Secondary | KOOS JR Score | This is a 6-item questionnaire that assesses patient reported knee pain and function. Score ranges from -100, with 100 representing the best score possible. | The morning of surgery and at the first post-operative visit, up to 4 months post-op. | |
Secondary | VR-12 Score | The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life. | The morning of surgery and at the first post-operative visit, up to 4 months post-op. | |
Secondary | Urine osmolality | Urine osmolality taken preoperatively, assess by medical record. | Measured preoperatively the morning of surgery. | |
Secondary | Urine specific gravity | Urine specific gravity preoperatively, assess by medical record. | Measured preoperatively the morning of surgery. | |
Secondary | In-house costs | In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay. | From admission to discharge, up to 1 week. |
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