Trial Outcomes & Findings for Blood Flow Restriction Following ACL Reconstruction (NCT NCT03758755)
NCT ID: NCT03758755
Last Updated: 2022-12-22
Results Overview
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Measured preoperatively and at 12 weeks post-op.
Results posted on
2022-12-22
Participant Flow
Patients were enrolled from two fellowship trained sports medicine orthopedic surgeons at a large health system from November 2018 to November 2021.
Of 49 enrolled patients, 45 met inclusion/exclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
BFR Therapy
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
20
|
|
Overall Study
COMPLETED
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 10.08 • n=25 Participants
|
29.0 years
STANDARD_DEVIATION 9.41 • n=20 Participants
|
26.8 years
STANDARD_DEVIATION 9.73 • n=45 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
13 Participants
n=20 Participants
|
32 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Laterality
Right
|
16 Participants
n=25 Participants
|
10 Participants
n=20 Participants
|
26 Participants
n=45 Participants
|
|
Laterality
Left
|
9 Participants
n=25 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=45 Participants
|
|
Type of Anterior Cruciate Ligament (ACL) Graft
Allograft
|
2 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
|
Type of Anterior Cruciate Ligament (ACL) Graft
Bone-Patellar Tendon-Bone Autograft
|
15 Participants
n=25 Participants
|
11 Participants
n=20 Participants
|
26 Participants
n=45 Participants
|
|
Type of Anterior Cruciate Ligament (ACL) Graft
Hamstring Tendon Autograft
|
5 Participants
n=25 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=45 Participants
|
|
Type of Anterior Cruciate Ligament (ACL) Graft
Quadriceps Tendon Autograft
|
3 Participants
n=25 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Measured preoperatively and at 12 weeks post-op.The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Questionnaire Score
Preoperative visit
|
47.40 score on a scale
Standard Error 8.00
|
50.80 score on a scale
Standard Error 4.01
|
|
International Knee Documentation Committee (IKDC) Questionnaire Score
12 weeks post-op
|
61.83 score on a scale
Standard Error 2.93
|
52.86 score on a scale
Standard Error 3.25
|
PRIMARY outcome
Timeframe: Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-opThe visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Visual Analog Score
Preoperative visit
|
2.36 score on a scale
Standard Error 0.50
|
3.18 score on a scale
Standard Error 1.02
|
|
Visual Analog Score
2 weeks post-op
|
2.72 score on a scale
Standard Error 0.65
|
3.16 score on a scale
Standard Error 0.63
|
|
Visual Analog Score
6 weeks post-op
|
1.00 score on a scale
Standard Error 0.26
|
1.51 score on a scale
Standard Error 0.56
|
|
Visual Analog Score
12 weeks post-op
|
0.29 score on a scale
Standard Error 0.30
|
1.16 score on a scale
Standard Error 0.37
|
PRIMARY outcome
Timeframe: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Quadriceps Tendon Strength
Week 2
|
58.88 percent difference to contralateral side
Standard Error 4.45
|
51.35 percent difference to contralateral side
Standard Error 5.85
|
|
Quadriceps Tendon Strength
Week 4
|
63.68 percent difference to contralateral side
Standard Error 3.37
|
66.13 percent difference to contralateral side
Standard Error 3.43
|
|
Quadriceps Tendon Strength
Week 6
|
75.73 percent difference to contralateral side
Standard Error 4.11
|
68.51 percent difference to contralateral side
Standard Error 3.33
|
|
Quadriceps Tendon Strength
Week 8
|
79.39 percent difference to contralateral side
Standard Error 2.07
|
72.88 percent difference to contralateral side
Standard Error 3.16
|
|
Quadriceps Tendon Strength
Week 10
|
80.22 percent difference to contralateral side
Standard Error 2.89
|
78.41 percent difference to contralateral side
Standard Error 5.11
|
|
Quadriceps Tendon Strength
Week 12
|
85.47 percent difference to contralateral side
Standard Error 3.84
|
73.03 percent difference to contralateral side
Standard Error 5.31
|
PRIMARY outcome
Timeframe: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Thigh Circumference
Perioperative
|
99.23 percent difference to contralateral side
Standard Error 1.65
|
101.62 percent difference to contralateral side
Standard Error 2.09
|
|
Thigh Circumference
2 weeks post-op
|
97.02 percent difference to contralateral side
Standard Error 1.11
|
97.68 percent difference to contralateral side
Standard Error 1.05
|
|
Thigh Circumference
4 weeks post-op
|
94.55 percent difference to contralateral side
Standard Error 0.82
|
97.11 percent difference to contralateral side
Standard Error 0.94
|
|
Thigh Circumference
6 weeks post-op
|
95.33 percent difference to contralateral side
Standard Error 1.05
|
95.55 percent difference to contralateral side
Standard Error 0.91
|
|
Thigh Circumference
8 weeks post-op
|
96.03 percent difference to contralateral side
Standard Error 0.71
|
95.76 percent difference to contralateral side
Standard Error 1.09
|
|
Thigh Circumference
10 weeks post-op
|
96.00 percent difference to contralateral side
Standard Error 0.71
|
96.46 percent difference to contralateral side
Standard Error 0.90
|
|
Thigh Circumference
12 weeks post-op
|
98.28 percent difference to contralateral side
Standard Error 0.61
|
98.27 percent difference to contralateral side
Standard Error 0.83
|
PRIMARY outcome
Timeframe: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Degrees of Knee Flexion
Perioperative Week
|
51.54 degrees
Standard Error 4.43
|
41.9 degrees
Standard Error 4.22
|
|
Degrees of Knee Flexion
2 weeks post-op
|
76.4 degrees
Standard Error 3.53
|
70.00 degrees
Standard Error 5.35
|
|
Degrees of Knee Flexion
4 weeks post-op
|
102.02 degrees
Standard Error 3.07
|
91.75 degrees
Standard Error 4.18
|
|
Degrees of Knee Flexion
6 weeks post-op
|
121.08 degrees
Standard Error 2.73
|
112.74 degrees
Standard Error 3.74
|
|
Degrees of Knee Flexion
8 weeks post-op
|
130.78 degrees
Standard Error 2.74
|
126.22 degrees
Standard Error 3.34
|
|
Degrees of Knee Flexion
10 weeks post-op
|
135.35 degrees
Standard Error 2.19
|
130.12 degrees
Standard Error 2.52
|
|
Degrees of Knee Flexion
12 weeks post-op
|
137.18 degrees
Standard Error 2.20
|
130.50 degrees
Standard Error 2.59
|
PRIMARY outcome
Timeframe: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Degrees of Knee Extension
Perioperative week
|
-6.88 degrees
Standard Error 1.40
|
-5.25 degrees
Standard Error 1.25
|
|
Degrees of Knee Extension
2 weeks post-op
|
-3.60 degrees
Standard Error 1.45
|
-3.20 degrees
Standard Error 0.84
|
|
Degrees of Knee Extension
4 weeks post-op
|
-0.32 degrees
Standard Error 0.73
|
-0.09 degrees
Standard Error 0.89
|
|
Degrees of Knee Extension
6 weeks post-op
|
0.68 degrees
Standard Error 0.51
|
-0.15 degrees
Standard Error 0.58
|
|
Degrees of Knee Extension
8 weeks post-op
|
1.22 degrees
Standard Error 0.64
|
0.63 degrees
Standard Error 0.73
|
|
Degrees of Knee Extension
10 weeks post-op
|
1.62 degrees
Standard Error 0.68
|
0.33 degrees
Standard Error 0.67
|
|
Degrees of Knee Extension
12 weeks post-op
|
1.59 degrees
Standard Error 0.63
|
0.31 degrees
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-opObservation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.
Outcome measures
| Measure |
BFR Therapy
n=25 Participants
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Blood Flow Restriction Therapy: A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
No BFR
n=20 Participants
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
ACL Reconstruction rehabilitation: post-operative rehabilitation according to current standards of care
|
|---|---|---|
|
Adverse Effects
|
0 adverse events
|
0 adverse events
|
Adverse Events
BFR Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No BFR
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