Osteoarthritis, KneeNCT06288815
Oral Fluid vs IV Fluid After Primary TKA
A study testing Oral fluid and IV fluid in people with Osteoarthritis, Knee and Total Knee Arthroplasty, run by Thammasat University Hospital at 1 site in Thailand.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee, Total Knee Arthroplasty, Oral Fluid Replacement
- What is being tested?
- Oral fluid and IV fluid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-85 years old
- ASA I, II
- Primary osteoarthritis
Who cannot join
- Diuretics use
- Morbid obesity
- Previous knee surgery
- Cannot undergo spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
Yot Tanariyakul, M.D., 663930257, y.tanariyakul@gmail.com
Nattapol Tammachote, M.D.
About this study
Official title: Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.
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?
- Being tested
- Oral fluid, IV fluid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fluidDietary supplement
Postoperation
- Off IV fluid immediately postoperative
- Allow patients drink oral fluid as protocol for 24hr
IV fluidDietary supplement
Postoperation
- IV fluid replacement as protocol for 24hr
- Allow patients drink oral fluid as usual
| Study group | Role | What they receive |
|---|---|---|
| Oral fluid | Experimental | * 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) Receives: Dietary Supplement: Oral fluid |
| IV fluid | Active comparator | * 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) Receives: Dietary Supplement: IV fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stand and walk
Stand and walk with walker
Measured: Postoperative day 1
Secondary outcomes (8)
Time up and go
Record time since stand up and walk 3 meters, or 10 feet away, on the floor
Measured: 24 and 48 hours
Incidence of oliguria
Urine output < 0.5ml/kg/hr
Measured: Postoperative day 1,2
Incidence of nausea/vomiting
record symptom of nausea and vomiting
Measured: Postoperative day 1,2
Urine specific gravity
Urine specific gravity every 4 hours
Measured: Postoperative day 1
the levels of certain electrolytes
Blood chemistry
Measured: Postoperative day 1,2
the levels of creatinine
Blood chemistry
Measured: Postoperative day 1,2
the levels of blood urea nitrogen (BUN).
Blood chemistry
Measured: Postoperative day 1,2
Complications
Pulmonary edema, heart failure, acute kidney injury
Measured: Until postoperative 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start10 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yot Tanariyakul, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288815
- Sponsor's protocol ID
- TUH oral fluid TKA
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32037213
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06288815
- Acronym / sponsor ID
- TUH oral fluid TKA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral fluid | Experimental | Dietary Supplement: 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) |
| IV fluid | Active comparator | Dietary Supplement: 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) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-85 years old
- ASA I, II
- Primary osteoarthritis
Key exclusion criteria (4 listed)
- Diuretics use
- Morbid obesity
- Previous knee surgery
- Cannot undergo spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral fluidPostoperation * Off IV fluid immediately postoperative * Allow patients drink oral fluid as protocol for 24hr | Dietary supplement | Oral fluid |
| IV fluidPostoperation * IV fluid replacement as protocol for 24hr * Allow patients drink oral fluid as usual | Dietary supplement | IV fluid |
Primary outcome
Time to stand and walk
Time frame: Postoperative day 1
Stand and walk with walker
8 secondary outcomes
Time up and go
Time frame: 24 and 48 hours
Incidence of oliguria
Time frame: Postoperative day 1,2
Incidence of nausea/vomiting
Time frame: Postoperative day 1,2
Urine specific gravity
Time frame: Postoperative day 1
the levels of certain electrolytes
Time frame: Postoperative day 1,2
the levels of creatinine
Time frame: Postoperative day 1,2
the levels of blood urea nitrogen (BUN).
Time frame: Postoperative day 1,2
Complications
Time frame: Until postoperative 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 32037213Jennings 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral fluid and IV fluid in people with Osteoarthritis, Knee and Total Knee Arthroplasty, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yot Tanariyakul, M.D. (663930257, y.tanariyakul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stand and walk (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.