Traditional vs Oral Fluid Management in Total Knee Arthro... | NCT03719378

Traditional vs Oral Fluid Management in Total Knee Arthro... | NCT03719378 | Trialant

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traditional Fluid	No Intervention	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
Oral Fluid	Experimental	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.	Other: Pre Operative Oral Fluids

Name	Type	Description	Arm Group Labels	Other Names
Pre Operative Oral Fluids	Other	Patients will be self hydrating prior to their total knee replacement.	Oral Fluid

Outcomes Module

Measure	Description	Time Frame
Body Weight	Patient Weight will be monitored	Change is patients weight from baseline at pre op to two weeks post op.

Secondary Outcomes

Measure	Description	Time Frame
Knee Range of Motion	Measurements will be done with a standard goniometer (Measurements below are shown as the difference from their pre operative base line measurement to the time points below)	Post Op Day 1, 2 Weeks and 6 Weeks Post Op
Leg Anthropometric (Girth) Measurements

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	episodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded	While in hospital until the 6 week follow up appointment
Blood Pressure

Contacts/Locations Module

Name	Affiliation	Role
Jason Jennings, MD	Colorado Joint Replacement	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Joint Replacement		Denver	Colorado	80210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19212167	Background	Marjanovic G, Villain C, Juettner E, zur Hausen A, Hoeppner J, Hopt UT, Drognitz O, Obermaier R. Impact of different crystalloid volume regimes on intestinal anastomotic stability. Ann Surg. 2009 Feb;249(2):181-5. doi: 10.1097/SLA.0b013e31818b73dc.
19943164	Background	Marjanovic G, Villain C, Timme S, zur Hausen A, Hoeppner J, Makowiec F, Holzner P, Hopt UT, Obermaier R. Colloid vs. crystalloid infusions in gastrointestinal surgery and their different impact on the healing of intestinal anastomoses. Int J Colorectal Dis. 2010 Apr;25(4):491-8. doi: 10.1007/s00384-009-0854-4. Epub 2009 Nov 27.

Arm/Group Information

ID	Title	Description
FG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
FG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00075 subjects FG00175 subjects
COMPLETED		FG00065 subjects FG00165 subjects
NOT COMPLETED		FG00010 subjects FG00110 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Body Weight

Patient Weight will be monitored

Posted

Mean

Standard Deviation

pounds

Change is patients weight from baseline at pre op to two weeks post op.

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
acute pulmonary embolism	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	Patient admired to the ER for an acute pulmonary embolism, this is a known risk of having a TKA, and was not related specifically to the study.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Rose Johnson, CCRP Research Lead	Colorado Joint Replacement	3032602940		roseannjohnson@centura.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 6, 2017	Oct 9, 2019	Prot_SAP_000.pdf

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0020

Title	Measurements
	BG0020

Secondary

Knee Range of Motion

Measurements will be done with a standard goniometer (Measurements below are shown as the difference from their pre operative base line measurement to the time points below)

Posted

Mean

Standard Deviation

degrees

Post Op Day 1, 2 Weeks and 6 Weeks Post Op

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Post Op Day 1

Title	Measurements
	OG000-30.5± 18.5 OG001-26.7± 16

2 Weeks Post Op

Title	Measurements
	OG000

Secondary

Leg Anthropometric (Girth) Measurements

measurements will be performed at 5 & 10 cm suprapatellar, midpatella, and 10 cm infrapatellar with the use of a standard tape measure. measurements below show the difference from their pre operative base line measurement to the timepoints below.

Posted

Mean

Standard Deviation

inches

Post op Day 1, 2 weeks and 6 weeks Post Op

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

(10 cm suprapatellar) Post Op day 1

Title	Measurements
	OG0002.5± 3.0 OG0012.1± 3.1

(10 cm suprapatellar) 2 weeks post op

Title	Measurements
	OG000

Secondary

Number of Participants With Requiring Transfusions

Post Operative/Intra Operative Transfusions

Posted

Count of Participants

Participants

intra operative, Post Op Day #1 or #2

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011

Secondary

Number of Participants With Off Wound Complications Post Operative

incidence of wound infection and wound drainage will be assessed and recorded

Posted

Count of Participants

Participants

Up to 6 weeks Post OP

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Secondary

Number of Participants With Thromboembolic Disease

The incidence of thromboembolic events will be recorded.

Posted

Count of Participants

Participants

Post Opeartive until the 6 week follow up appointment

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010

Secondary

Quadriceps Strength Measure With a Handheld Dynamometer

The strength testing will be calculated using a handheld dynamometer

Posted

Mean

Standard Deviation

Post Op day 1, 2 Week and 6 Week Post OP

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop to Post Op Day1

Title	Measurements
	OG000-10.4± 7.6 OG001-11.2± 7.1

Change from Preop to 2 weeks post op

Title	Measurements
	OG000

Secondary

Time up and GO

timed up and go (TUG)

Posted

Mean

Standard Deviation

Seconds

preoperative appointment and once again at their 2 and 6 weeks postoperatively

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop to 2 weeks Post op

Title	Measurements
	OG0004.4± 4.8 OG0013.3± 3.7

Change from Preop to 6 weeks Post op

Title	Measurements
	OG000

Secondary

30 Second STS Test

30 second sit-to-stand tests

Posted

Mean

Standard Deviation

sit-to-stand events

preoperative appointment and once again at their 2 and 6 weeks postoperatively

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop to 2 weeks Post op

Title	Measurements
	OG000-5.3± 4.0 OG001-4.4± 4.6

Change from Preop to 6 weeks Post op

Title	Measurements
	OG000

Secondary

Length of the Hospitalization

Length of time the patient is Hospitalized after their total knee replacement.

Posted

Count of Participants

Participants

Daily up to 2 days while hospitalized

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
1 Day	OG00056 OG00163
2 Days	OG0009

Secondary

Number of Patients Re-admitted Post TKA

Number of patients re-admitted post TKA

Posted

Count of Participants

Participants

up to 6 weeks post op

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010

Secondary

Postoperative Pain Assessment Using Visual Analog Scale

Pain will be assessed using a pain Visual Analog scale(VAS), the scale is from 1 to 10, the higher the score the worse the pain.

Some of the patients did not complete their pain log for the study, which is why the numbers are different below.

Posted

Mean

Standard Deviation

units on a scale

Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day)

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Average Post Op Day 1

- ParticipantsOG00065
- ParticipantsOG00165

Title	Measurements
	OG0002.6± 1.4

Secondary

PONV (Post-operative Nausea and Vomiting)

patients will be asked about Nausea: None, Mild, Moderate or Severe

Posted

Count of Participants

Participants

Daily up to 2 days while hospitalized

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

None

Title	Measurements
	OG00051 OG00146

Mild

Title	Measurements
	OG000

Secondary

Veterans Rand -12

Patient Reported Outcomes- Veterans Rand(VR-12), there is an algorithm to calculate this score, not a specific range. The higher the number the more positive the output. The score has two components a mental score (MCS) and Physical Score (PCS). Higher values represent a better outcome.

MCS Scale 35.089613 to 46.341715 PCS Scale 14.957554 to 63.235672

Posted

Mean

Standard Deviation

score on a scale

2 week and 6 week follow up appointments

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop - 2 Weeks Post Op Mental Score

Title	Measurements
	OG000-4.7± 12.2 OG001-1.2± 10.4

Change from Preop - 2 Weeks PostOp Physical Score

Title	Measurements
	OG000

Secondary

Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.

Posted

Mean

Standard Deviation

score on a scale

pre-operatively as well as at their 2 week and 6 week follow up appointments

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change is score from pre op to 2 weeks

Title	Measurements
	OG000-1.6± 16.2 OG0013.1± 13.8

Change is score from pre op to 6 weeks

Title	Measurements
	OG000

Secondary

Patient Reported Outcomes - Knee Society Score(KSS)

Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.

Posted

Mean

Standard Deviation

score on a scale

pre-operatively as well as at their 2 week and 6 week follow up appointments

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop to 2 weeks Post op

Title	Measurements
	OG000-14.6± 39.9 OG001-0.2± 36.2

Change from pre op to 6 weeks

Title	Measurements
	OG000

Secondary

Total IV Fluids Received

Total amount of IV fluids that the patients received while in the hospital

Posted

Median

Inter-Quartile Range

Duration of IV intervention, up to 2 days

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0003895(1500 to 5322) OG001350(177 to 1466)

Secondary

Bioimpedence

body composition before and after surgery to measure swelling. Lower numbers represent more swelling.

Posted

Mean

Standard Deviation

ohms

pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change from Preop to Post Op Day1

Title	Measurements
	OG000-17.8± 30.3 OG0014.2± 29.7

Change from Preop to 2 weeks post op

Title	Measurements
	OG000

Other Pre-specified

Number of Participants With Adverse Events

episodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded

Posted

Count of Participants

Participants

While in hospital until the 6 week follow up appointment

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0012

Other Pre-specified

Blood Pressure

Blood Pressure (Diastolic/ Systolic)

Posted

Mean

Standard Deviation

Change in mmHg

Daily up to 2 days while hospitalized

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Change in mmHg Pre Op to Recovery Room (Systolic)

Title	Measurements
	OG00021.5± 15.9 OG00126.0± 16.7

Change in mmHg Pre Op to Recovery Room (Diastolic)

Title	Measurements
	OG000

Other Pre-specified

Total Number of Patients That Received Any Pressor Drugs

total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)

Posted

Count of Participants

Participants

Up to Day 1 Post op

ID	Title	Description
OG000	Traditional Fluid	NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively.
OG001	Oral Fluid	Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement.

Units	Counts
Participants	OG00065 OG00165

Title

Denominators

Categories

Title	Measurements
Yes	OG00023 OG00122
No	OG00042