Oral Fluid vs IV Fluid After Primary TKA

NCT ID: NCT06288815

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.

The main question it aims to answer is:

Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee Total Knee Arthroplasty Oral Fluid Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral fluid

* NPO (8hr for food, 2hr for water)
* Intraoperative IV fluid at least 1 liter
* Post operative (Off IV fluid, allow oral fluid as protocol at least 24hr)

Group Type EXPERIMENTAL

Oral fluid

Intervention Type DIETARY_SUPPLEMENT

Postoperation

* Off IV fluid immediately postoperative
* Allow patients drink oral fluid as protocol for 24hr

IV fluid

* NPO (8hr for food, 2hr for water)
* Intraoperative IV fluid at least 1 liter
* Post operative (IV fluid as protocol at least 24hr, allow oral fluid as usual)

Group Type ACTIVE_COMPARATOR

IV fluid

Intervention Type DIETARY_SUPPLEMENT

Postoperation

* IV fluid replacement as protocol for 24hr
* Allow patients drink oral fluid as usual

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral fluid

Postoperation

* Off IV fluid immediately postoperative
* Allow patients drink oral fluid as protocol for 24hr

Intervention Type DIETARY_SUPPLEMENT

IV fluid

Postoperation

* IV fluid replacement as protocol for 24hr
* Allow patients drink oral fluid as usual

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 40-85 years old
* ASA I, II
* Primary osteoarthritis

Exclusion Criteria

* Diuretics use
* Morbid obesity
* Previous knee surgery
* Cannot undergo spinal anesthesia
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thammasat University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yot Tanariyakul

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yot Tanariyakul, M.D.

Role: CONTACT

663930257

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yot Tanariyakul, M.D.

Role: primary

663930257

References

Explore related publications, articles, or registry entries linked to this study.

Jennings JM, Mejia M, Williams MA, Johnson RM, Yang CC, Dennis DA. The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S3-S9. doi: 10.1016/j.arth.2020.01.029. Epub 2020 Jan 22.

Reference Type BACKGROUND
PMID: 32037213 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TUH oral fluid TKA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mepiform in Simultaneous Bilateral TKA
NCT06312527 ACTIVE_NOT_RECRUITING NA
Cemented vs Cementless TKA
NCT03683992 COMPLETED