Trial Outcomes & Findings for Traditional vs Oral Fluid Management in Total Knee Arthroplasty (NCT NCT03719378)
NCT ID: NCT03719378
Last Updated: 2021-03-16
Results Overview
Patient Weight will be monitored
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Change is patients weight from baseline at pre op to two weeks post op.
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Traditional Fluid
n=75 Participants
* 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
n=75 Participants
* 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.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 Years
STANDARD_DEVIATION 7.5 • n=75 Participants
|
60.9 Years
STANDARD_DEVIATION 6.8 • n=75 Participants
|
61 Years
STANDARD_DEVIATION 7.2 • n=150 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=75 Participants
|
42 Participants
n=75 Participants
|
86 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=75 Participants
|
33 Participants
n=75 Participants
|
64 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
75 participants
n=75 Participants
|
75 participants
n=75 Participants
|
150 participants
n=150 Participants
|
|
BMI
|
28.5 kg/m^2 (BMI)
STANDARD_DEVIATION 4.9 • n=75 Participants
|
28.1 kg/m^2 (BMI)
STANDARD_DEVIATION 4.2 • n=75 Participants
|
28.3 kg/m^2 (BMI)
STANDARD_DEVIATION 4.6 • n=150 Participants
|
PRIMARY outcome
Timeframe: Change is patients weight from baseline at pre op to two weeks post op.Patient Weight will be monitored
Outcome measures
| Measure |
Traditional Fluid
n=64 Participants
* 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
n=64 Participants
* 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.
|
|---|---|---|
|
Body Weight
|
-1.9 pounds
Standard Deviation 4.4
|
-1.6 pounds
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Post Op Day 1, 2 Weeks and 6 Weeks Post OpMeasurements 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)
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Knee Range of Motion
Post Op Day 1
|
-30.5 degrees
Standard Deviation 18.5
|
-26.7 degrees
Standard Deviation 16
|
|
Knee Range of Motion
2 Weeks Post Op
|
-27.9 degrees
Standard Deviation 17.5
|
-25.5 degrees
Standard Deviation 16.5
|
|
Knee Range of Motion
6 Weeks Post OP
|
-7.7 degrees
Standard Deviation 17
|
-4.8 degrees
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Post op Day 1, 2 weeks and 6 weeks Post Opmeasurements 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.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Leg Anthropometric (Girth) Measurements
(10 cm suprapatellar) Post Op day 1
|
2.5 inches
Standard Deviation 3.0
|
2.1 inches
Standard Deviation 3.1
|
|
Leg Anthropometric (Girth) Measurements
(10 cm suprapatellar) 2 weeks post op
|
0.9 inches
Standard Deviation 3.0
|
1.6 inches
Standard Deviation 4.0
|
|
Leg Anthropometric (Girth) Measurements
(10 cm suprapatellar) 6 weeks post op
|
0.00 inches
Standard Deviation 2.6
|
0.00 inches
Standard Deviation 3.3
|
|
Leg Anthropometric (Girth) Measurements
(5 cm suprapatellar) Post Op day 1
|
4.1 inches
Standard Deviation 2.4
|
4.0 inches
Standard Deviation 2.6
|
|
Leg Anthropometric (Girth) Measurements
(5 cm suprapatellar) 2 weeks post op
|
2.0 inches
Standard Deviation 2.3
|
2.8 inches
Standard Deviation 2.6
|
|
Leg Anthropometric (Girth) Measurements
(5 cm suprapatellar) 6 weeks post op
|
0.9 inches
Standard Deviation 1.9
|
1.0 inches
Standard Deviation 2.2
|
|
Leg Anthropometric (Girth) Measurements
(Midpatellar) Post Op day 1
|
4.6 inches
Standard Deviation 2.2
|
4.1 inches
Standard Deviation 2.6
|
|
Leg Anthropometric (Girth) Measurements
(Midpatellar) 2 weeks post op
|
2.2 inches
Standard Deviation 2.3
|
3.0 inches
Standard Deviation 2.0
|
|
Leg Anthropometric (Girth) Measurements
(Midpatellar) 6 weeks post op
|
1.3 inches
Standard Deviation 1.6
|
1.3 inches
Standard Deviation 2.0
|
|
Leg Anthropometric (Girth) Measurements
(10 cm inferior patella) Post Op day 1
|
2.7 inches
Standard Deviation 2.7
|
1.5 inches
Standard Deviation 4.6
|
|
Leg Anthropometric (Girth) Measurements
(10 cm inferior patella) 2 weeks post op
|
0.8 inches
Standard Deviation 2.1
|
0.9 inches
Standard Deviation 2.3
|
|
Leg Anthropometric (Girth) Measurements
(10 cm inferior patella) 6 weeks post op
|
-0.2 inches
Standard Deviation 1.3
|
0.1 inches
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: intra operative, Post Op Day #1 or #2Post Operative/Intra Operative Transfusions
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Number of Participants With Requiring Transfusions
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks Post OPincidence of wound infection and wound drainage will be assessed and recorded
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Number of Participants With Off Wound Complications Post Operative
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post Opeartive until the 6 week follow up appointmentThe incidence of thromboembolic events will be recorded.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Number of Participants With Thromboembolic Disease
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post Op day 1, 2 Week and 6 Week Post OPThe strength testing will be calculated using a handheld dynamometer
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Quadriceps Strength Measure With a Handheld Dynamometer
Change from Preop to Post Op Day1
|
-10.4 KG
Standard Deviation 7.6
|
-11.2 KG
Standard Deviation 7.1
|
|
Quadriceps Strength Measure With a Handheld Dynamometer
Change from Preop to 2 weeks post op
|
-9.0 KG
Standard Deviation 6.5
|
-9.6 KG
Standard Deviation 7.2
|
|
Quadriceps Strength Measure With a Handheld Dynamometer
Change from Preop to 6 weeks post op
|
-3.2 KG
Standard Deviation 5.8
|
-3.8 KG
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: preoperative appointment and once again at their 2 and 6 weeks postoperativelytimed up and go (TUG)
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Time up and GO
Change from Preop to 2 weeks Post op
|
4.4 Seconds
Standard Deviation 4.8
|
3.3 Seconds
Standard Deviation 3.7
|
|
Time up and GO
Change from Preop to 6 weeks Post op
|
-4.7 Seconds
Standard Deviation 3.5
|
-4.0 Seconds
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: preoperative appointment and once again at their 2 and 6 weeks postoperatively30 second sit-to-stand tests
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
30 Second STS Test
Change from Preop to 2 weeks Post op
|
-5.3 sit-to-stand events
Standard Deviation 4.0
|
-4.4 sit-to-stand events
Standard Deviation 4.6
|
|
30 Second STS Test
Change from Preop to 6 weeks Post op
|
-0.4 sit-to-stand events
Standard Deviation 4.1
|
0.3 sit-to-stand events
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Daily up to 2 days while hospitalizedLength of time the patient is Hospitalized after their total knee replacement.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Length of the Hospitalization
1 Day
|
56 Participants
|
63 Participants
|
|
Length of the Hospitalization
2 Days
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeks post opNumber of patients re-admitted post TKA
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Number of Patients Re-admitted Post TKA
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: Some of the patients did not complete their pain log for the study, which is why the numbers are different below.
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.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Post Op Day 1
|
2.6 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.4
|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Post Op Day 2
|
4.4 units on a scale
Standard Deviation 1.5
|
4.5 units on a scale
Standard Deviation 1.6
|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Week 1
|
4.3 units on a scale
Standard Deviation 1.6
|
4.1 units on a scale
Standard Deviation 1.6
|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Week 2
|
3.6 units on a scale
Standard Deviation 1.8
|
3.4 units on a scale
Standard Deviation 1.5
|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Week 3
|
3.0 units on a scale
Standard Deviation 1.7
|
3.2 units on a scale
Standard Deviation 1.7
|
|
Postoperative Pain Assessment Using Visual Analog Scale
Average Week 4
|
2.7 units on a scale
Standard Deviation 1.6
|
2.6 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Daily up to 2 days while hospitalizedpatients will be asked about Nausea: None, Mild, Moderate or Severe
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
PONV (Post-operative Nausea and Vomiting)
None
|
51 Participants
|
46 Participants
|
|
PONV (Post-operative Nausea and Vomiting)
Mild
|
9 Participants
|
12 Participants
|
|
PONV (Post-operative Nausea and Vomiting)
Moderat
|
3 Participants
|
3 Participants
|
|
PONV (Post-operative Nausea and Vomiting)
Severe
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 week and 6 week follow up appointmentsPatient 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
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Veterans Rand -12
Change from Preop - 2 Weeks Post Op Mental Score
|
-4.7 score on a scale
Standard Deviation 12.2
|
-1.2 score on a scale
Standard Deviation 10.4
|
|
Veterans Rand -12
Change from Preop - 2 Weeks PostOp Physical Score
|
-8.3 score on a scale
Standard Deviation 10
|
-4.5 score on a scale
Standard Deviation 11.2
|
|
Veterans Rand -12
Change from Pre op - 6 Weeks Post Op Mental Score
|
-2.5 score on a scale
Standard Deviation 11.5
|
-3.2 score on a scale
Standard Deviation 11.4
|
|
Veterans Rand -12
Change from Preop - 6 Weeks PostOp Physical Score
|
-0.5 score on a scale
Standard Deviation 10.6
|
2.2 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: pre-operatively as well as at their 2 week and 6 week follow up appointmentsKnee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change is score from pre op to 2 weeks
|
-1.6 score on a scale
Standard Deviation 16.2
|
3.1 score on a scale
Standard Deviation 13.8
|
|
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change is score from pre op to 6 weeks
|
9.4 score on a scale
Standard Deviation 14.5
|
12.3 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: pre-operatively as well as at their 2 week and 6 week follow up appointmentsKnee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Patient Reported Outcomes - Knee Society Score(KSS)
Change from Preop to 2 weeks Post op
|
-14.6 score on a scale
Standard Deviation 39.9
|
-0.2 score on a scale
Standard Deviation 36.2
|
|
Patient Reported Outcomes - Knee Society Score(KSS)
Change from pre op to 6 weeks
|
31.9 score on a scale
Standard Deviation 36.3
|
40.5 score on a scale
Standard Deviation 35.4
|
SECONDARY outcome
Timeframe: Duration of IV intervention, up to 2 daysTotal amount of IV fluids that the patients received while in the hospital
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Total IV Fluids Received
|
3895 ML
Interval 1500.0 to 5322.0
|
350 ML
Interval 177.0 to 1466.0
|
SECONDARY outcome
Timeframe: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visitbody composition before and after surgery to measure swelling. Lower numbers represent more swelling.
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Bioimpedence
Change from Preop to Post Op Day1
|
-17.8 ohms
Standard Deviation 30.3
|
4.2 ohms
Standard Deviation 29.7
|
|
Bioimpedence
Change from Preop to 2 weeks post op
|
-41.4 ohms
Standard Deviation 34.2
|
-38.5 ohms
Standard Deviation 45.7
|
|
Bioimpedence
Change from Preop to 6 weeks post op
|
-30.9 ohms
Standard Deviation 25.6
|
-31.0 ohms
Standard Deviation 31.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: While in hospital until the 6 week follow up appointmentepisodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily up to 2 days while hospitalizedBlood Pressure (Diastolic/ Systolic)
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Blood Pressure
Change in mmHg Pre Op to Recovery Room (Systolic)
|
21.5 Change in mmHg
Standard Deviation 15.9
|
26.0 Change in mmHg
Standard Deviation 16.7
|
|
Blood Pressure
Change in mmHg Pre Op to Recovery Room (Diastolic)
|
18.4 Change in mmHg
Standard Deviation 12.2
|
17.2 Change in mmHg
Standard Deviation 11.9
|
|
Blood Pressure
Change in mmHg Pre Op to Arrival on 4th floor (Systolic)
|
10.6 Change in mmHg
Standard Deviation 12.8
|
19.4 Change in mmHg
Standard Deviation 13.5
|
|
Blood Pressure
Change in mmHg Pre Op to Arrival on 4th floor (Diastolic)
|
10.5 Change in mmHg
Standard Deviation 10.3
|
9.3 Change in mmHg
Standard Deviation 10.8
|
|
Blood Pressure
Change in mmHg Pre Op to 08:00 on floor (Systolic)
|
17.0 Change in mmHg
Standard Deviation 12.9
|
23.4 Change in mmHg
Standard Deviation 13.3
|
|
Blood Pressure
Change in mmHg Pre Op to 08:00 on floor (Diastolic)
|
16.5 Change in mmHg
Standard Deviation 9.3
|
16.0 Change in mmHg
Standard Deviation 9.6
|
|
Blood Pressure
Change in mmHg Pre Op to 16:00 on floor (Systolic)
|
20.9 Change in mmHg
Standard Deviation 14.0
|
25.8 Change in mmHg
Standard Deviation 13.8
|
|
Blood Pressure
Change in mmHg Pre Op to 16:00 on floor (Diastolic)
|
16.3 Change in mmHg
Standard Deviation 11.2
|
18.7 Change in mmHg
Standard Deviation 11.8
|
|
Blood Pressure
Change in mmHg Pre Op to 24:00 on floor (Systolic)
|
12.5 Change in mmHg
Standard Deviation 14.7
|
12.5 Change in mmHg
Standard Deviation 12.9
|
|
Blood Pressure
Change in mmHg Pre Op to 24:00 on floor (Diastolic)
|
14.6 Change in mmHg
Standard Deviation 9.9
|
11.1 Change in mmHg
Standard Deviation 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 1 Post optotal amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)
Outcome measures
| Measure |
Traditional Fluid
n=65 Participants
* 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
n=65 Participants
* 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.
|
|---|---|---|
|
Total Number of Patients That Received Any Pressor Drugs
Yes
|
23 Participants
|
22 Participants
|
|
Total Number of Patients That Received Any Pressor Drugs
No
|
42 Participants
|
43 Participants
|
Adverse Events
Traditional Fluid
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Fluid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Traditional Fluid
n=65 participants at risk
* 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
n=65 participants at risk
* 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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute pulmonary embolism
|
1.5%
1/65 • Number of events 1 • 6 Weeks Post Operatively
|
0.00%
0/65 • 6 Weeks Post Operatively
|
Other adverse events
Adverse event data not reported
Additional Information
Rose Johnson, CCRP Research Lead
Colorado Joint Replacement
Phone: 3032602940
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place