Trial Outcomes & Findings for Ischemic Preconditioning in Total Knee Arthroplasty (NCT NCT01333969)
NCT ID: NCT01333969
Last Updated: 2024-12-27
Results Overview
Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
48hrs after surgery
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Ishcemic Preconditioning
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ischemic Preconditioning in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
66.5 years
n=5 Participants
|
72.5 years
n=7 Participants
|
70.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48hrs after surgeryVisual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
VAS score at rest
|
1.75 score on a scale
Interval 0.02 to 2.25
|
.71 score on a scale
Interval 0.02 to 1.4
|
|
Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
VAS score with exercise
|
3 score on a scale
Interval 1.8 to 4.2
|
1.38 score on a scale
Interval 0.44 to 2.32
|
SECONDARY outcome
Timeframe: At 48hrs after surgeryPostoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Overall Epidural Volume
|
140.5 mL
Standard Deviation 68.4
|
160.8 mL
Standard Deviation 70.1
|
SECONDARY outcome
Timeframe: At 48 hrs after surgerymuscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively
Outcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Muscle Oxygenation Over Calf at 48h After Surgery
|
75 percentage of muscle tissue
Standard Deviation 22.4
|
69 percentage of muscle tissue
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: At 24 hours postoperativelyPopulation: IL-6 levels could not be measured for all patients.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=24 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=28 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively
|
3.79 pg/ml
Interval 2.4 to 6.6
|
3.57 pg/ml
Interval 2.3 to 7.4
|
SECONDARY outcome
Timeframe: measured at 6 hours, 24 hours, and 48 hoursPeriarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Periarticular Circumference of the Knee at 6h, 24h, and 48h
|
2.3 cm
Standard Deviation 3.2
|
1.5 cm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to discharge dateOutcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Hospital Length of Stay
|
100.6 hours
Interval 56.2 to 145.0
|
99.4 hours
Interval 63.4 to 135.4
|
SECONDARY outcome
Timeframe: Up to discharge dateAmount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission
Outcome measures
| Measure |
Ishcemic Preconditioning
n=30 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=30 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Physical Therapy Milestone
|
2.0 days
Interval 1.0 to 3.0
|
3.0 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: some patients were lost to follow up.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=23 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=25 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively
|
2487 cells/mm^3
Standard Deviation 2415.74
|
2038 cells/mm^3
Standard Deviation 1778.74
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: some patients were lost to follow up.
Outcome measures
| Measure |
Ishcemic Preconditioning
n=28 Participants
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).
Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
Control
n=29 Participants
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
|
|---|---|---|
|
Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively
|
3.72 pg/ml
Interval 3.09 to 4.65
|
3.76 pg/ml
Interval 3.05 to 5.82
|
Adverse Events
Ishcemic Preconditioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place