Trial Outcomes & Findings for Tourniquet Pressure in Primary Total Knee Arthroplasty (NCT NCT02830087)

Results Overview

Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Postoperative Day 1 through two weeks

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Overall Study STARTED	4	4	4	3	3	3
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	4	4	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Overall Study No study staff to follow-up patients	4	4	4	3	3	3

Baseline Characteristics

Tourniquet Pressure in Primary Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	220 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	14 Participants n=115 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants
Age, Continuous	63 years STANDARD_DEVIATION 6.7 • n=5 Participants	58.3 years STANDARD_DEVIATION 8.9 • n=7 Participants	59.5 years STANDARD_DEVIATION 8.9 • n=5 Participants	63.7 years STANDARD_DEVIATION 13.2 • n=4 Participants	50.7 years STANDARD_DEVIATION 7.2 • n=21 Participants	73.7 years STANDARD_DEVIATION 2.1 • n=10 Participants	61.3 years STANDARD_DEVIATION 9.6 • n=115 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	11 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	10 Participants n=115 Participants
Region of Enrollment United States	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	21 Participants n=115 Participants

PRIMARY outcome

Timeframe: Postoperative Day 1 through two weeks

Population: data not collected for all participants

Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Postoperative Pain	—	—	3 score on a scale	7 score on a scale	—	9 score on a scale

SECONDARY outcome

Timeframe: Postoperative Day 2

Population: No data collected

Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-week follow-up

Population: data not collected for all participants

Measure degrees of knee flexion

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Range of Motion	—	—	78 Degrees	15 Degrees	—	—

SECONDARY outcome

Timeframe: Intraoperative

Population: data not collected for all participants

four-point scale: * 1 = bloodless * 2 = nearly bloodless, some bleeding * 3 = bloody, tourniquet no better than not using * 4 = venous tourniquet, tourniquet making things worse Higher scores denotes worse outcome

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure n=2 Participants Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Intra-operative Bloodlessness	—	1 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant	1 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant	2 score on a scale Standard Deviation 1.4	—	—

SECONDARY outcome

Timeframe: Postoperative Day 1 through 12 week follow-up

Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=4 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure n=3 Participants Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Number of Participants With Wound Healing Issues	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: One Year Follow-up

Population: No data collected

Number of participants that needed a revision was necessary within one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Postoperative Day 1 through Postoperative Day 2

Population: data not collected for all participants

Distance Walked in Feet

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Ability to Ambulate	—	—	208 Feet	—	—	—

SECONDARY outcome

Timeframe: 2-week follow-up through 12-week follow-up

Population: data not collected for all participants

Six Point Strength Scale 0 - No muscle movement 1. -Muscle movement, without movement at the joint 2. -Movement at the joint, but not against gravity 3. -Movement against gravity, but not against resistance 4. -Movement against resistance, but less than full strength 5. -Full Strength Higher scores denotes better outcome

Outcome measures

Outcome measures
Measure	220 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 220 mmHg. Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	250 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 250 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	275 mmHg Tourniquet Cuff Pressure n=1 Participants Thigh tourniquet cuff inflated to 275 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	300 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 300 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	325 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 325 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.	350 mmHg Tourniquet Cuff Pressure Thigh tourniquet cuff inflated to 350 mmHg Tourniquet Cuff Pressure: Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
Quadriceps Strength	—	—	4 score on a scale	—	—	—

SECONDARY outcome

Timeframe: 6-week follow-up through 12-week follow-up

Population: No data collected

Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks