NCT05520593

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2022Jan 2027

First Submitted

Initial submission to the registry

August 24, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

August 24, 2022

Last Update Submit

April 8, 2026

Conditions

Same-day DischargeLength of Stay

Keywords

Carbohydrate DrinkPerioperative FluidsSame-day DischargeTotal Joint ArthroplastyNauseaVomitingSame-day total hip arthroplastySame-day total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Same day discharge rate

    Through study completion, an average of 3 months.

  • Number of physical therapy sessions attempted

    From admission to discharge, up to 1 week.

  • Total distance walked

    From admission to discharge, up to 1 week.

  • Number of stairs climbed

    From admission to discharge, up to 1 week.

  • Orthostatic hypotension episodes

    During physical therapy attempts, from admission to discharge.

  • +6 more secondary outcomes

Study Arms (2)

Complex Carbohydrate Drink Group

EXPERIMENTAL

The patients will drink a 400ml drink that contains 50g of complex carbohydrates, 3 hours prior to the surgery. The drink will be given once at the preoperative holding area. Patients are not allowed to eat solid foods after 12am the morning of surgery and can only drink clear fluids up to 3 hours prior to the surgery.

Dietary Supplement: Complex Carbohydrate Drink

No-Complex Carbohydrate Drink Group

NO INTERVENTION

These patients will follow normal institutional preoperative fluid management guidelines, this consist of no solid foods after 12am the morning of surgery. Patients are allowed to drink clear liquids (water, clear fruit juices, coffee) from 12am the morning of surgery up to 3 hours prior to the surgery.

Interventions

Complex Carbohydrate DrinkDIETARY_SUPPLEMENT

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

Complex Carbohydrate Drink Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

NauseaVomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose A Rodriguez, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Rodriguez, MD

CONTACT

212-552-5829rodriguezjose@hss.edu

Ricardo Torres-Ramirez, BS

CONTACT

212-260-3763torresr@hss.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Orthopaedic Surgery

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 30, 2022

Study Start

November 7, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)