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NCT Number: NCT05520593

Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Alejandro Gonzalez Della Valle, MD

SUB_INVESTIGATOR

Michael Ast, MD

SUB_INVESTIGATOR

Ricardo Torres, BS

CONTACT

[email protected]

2122603763

Ricardo Torres, BS

SUB_INVESTIGATOR

Samuel Rodriguez, MD

SUB_INVESTIGATOR

Stravos Memtsoudis, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

complex carbohydrate drink

Dietary Supplement

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

Primary outcomes

  1. Length of hospital stay in hours

    Time frame: From admission to discharge, up to 1 week

    Length of hospital stay in hours, assess by medical record.

Secondary outcomes

  1. Same day discharge rate

    Time frame: Through study completion, an average of 3 months.

    Percentage of patients discharged successfully the day of surgery.

  2. Number of physical therapy sessions attempted

    Time frame: From admission to discharge, up to 1 week.

    Number of physical therapy sessions attempted, assess by medical record.

  3. Total distance walked

    Time frame: From admission to discharge, up to 1 week.

    Total distance walked during physical therapy attempts, assess by medical record.

  4. Number of stairs climbed

    Time frame: From admission to discharge, up to 1 week.

    Number of stairs climbed during physical therapy attempts, assess by medical record.

  5. Orthostatic hypotension episodes

    Time frame: During physical therapy attempts, from admission to discharge.

    Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.

  6. HOOS JR Score

    Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.

    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.

  7. KOOS JR Score

    Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.

    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.

  8. VR-12 Score

    Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.

    The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life.

  9. Urine osmolality

    Time frame: Measured preoperatively the morning of surgery.

    Urine osmolality taken preoperatively, assess by medical record.

  10. Urine specific gravity

    Time frame: Measured preoperatively the morning of surgery.

    Urine specific gravity preoperatively, assess by medical record.

  11. In-house costs

    Time frame: From admission to discharge, up to 1 week.

    In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Rodriguez, MD

CONTACT

[email protected]

212-552-5829

Ricardo Torres-Ramirez, BS

CONTACT

[email protected]

212-260-3763

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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