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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05520593
Other study ID # 2020-2597
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date January 24, 2025

Study information

Verified date May 2024
Source Hospital for Special Surgery, New York
Contact Jose Rodriguez, MD
Phone 212-552-5829
Email rodriguezjose@hss.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The way total joint arthroplasty is practiced continues to evolve as CMS removed total hip arthroplasty (THA) from the inpatient-only list and added total knee arthroplasty (TKA) to the ASC Covered Surgical Procedures List (CPL) in 2020. Thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. Current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. Considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Complex Carbohydrate Drink
Patients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area.

Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

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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