Trial Outcomes & Findings for Blood Flow Restriction After Meniscus Repair (NCT NCT04436523)
NCT ID: NCT04436523
Last Updated: 2026-02-20
Results Overview
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
TERMINATED
NA
15 participants
Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
2026-02-20
Participant Flow
Participant milestones
| Measure |
Blood Flow Restriction Group
This group underwent physical therapy with BFR intervention.
|
Control Group
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
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 |
Blood Flow Restriction
n=7 Participants
The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
Blood flow restriction (Delfi Personalized Tourniquet System): The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Standard rehabilitation: Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
|
Standard Rehabilitation
n=8 Participants
The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.
Standard rehabilitation: Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 12.6 • n=8 Participants
|
37.3 years
STANDARD_DEVIATION 10.4 • n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=8 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 1
Involved Limb
|
36.9 lbs
Standard Deviation 30.3
|
21.0 lbs
Standard Deviation 11.1
|
|
Knee Extension Force at Week 1
Contralateral Limb
|
87.1 lbs
Standard Deviation 42.4
|
95.6 lbs
Standard Deviation 54.7
|
PRIMARY outcome
Timeframe: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 2
Involved Limb
|
38.9 lbs
Standard Deviation 29.8
|
33.7 lbs
Standard Deviation 7.4
|
|
Knee Extension Force at Week 2
Contralateral Limb
|
93.0 lbs
Standard Deviation 39.2
|
70.2 lbs
Standard Deviation 34.8
|
PRIMARY outcome
Timeframe: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 3
Involved Limb
|
45.3 lbs
Standard Deviation 34.3
|
29.6 lbs
Standard Deviation 6.3
|
|
Knee Extension Force at Week 3
Contralateral Limb
|
110.3 lbs
Standard Deviation 32.9
|
76.2 lbs
Standard Deviation 51.2
|
PRIMARY outcome
Timeframe: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 4
Involved limb
|
48.0 lbs
Standard Deviation 39.1
|
28.9 lbs
Standard Deviation 4.0
|
|
Knee Extension Force at Week 4
Contralateral limb
|
112.1 lbs
Standard Deviation 27.9
|
91.5 lbs
Standard Deviation 34.0
|
PRIMARY outcome
Timeframe: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 5
Involved limb
|
49.7 lbs
Standard Deviation 36.5
|
29.7 lbs
Standard Deviation 7.3
|
|
Knee Extension Force at Week 5
Contralateral limb
|
117.8 lbs
Standard Deviation 19.4
|
96.5 lbs
Standard Deviation 37.5
|
PRIMARY outcome
Timeframe: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=8 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 6
Involved limb
|
62.3 lbs
Standard Deviation 47.0
|
46.0 lbs
Standard Deviation 18.8
|
|
Knee Extension Force at Week 6
Contralateral limb
|
118.8 lbs
Standard Deviation 26.3
|
101.6 lbs
Standard Deviation 33.2
|
PRIMARY outcome
Timeframe: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 7
Involved limb
|
64.9 lbs
Standard Deviation 48.1
|
55.8 lbs
Standard Deviation 16.6
|
|
Knee Extension Force at Week 7
Contralateral limb
|
121.5 lbs
Standard Deviation 25.3
|
98.5 lbs
Standard Deviation 35.8
|
PRIMARY outcome
Timeframe: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=4 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 8
Involved limb
|
77.7 lbs
Standard Deviation 45.5
|
61.2 lbs
Standard Deviation 31.4
|
|
Knee Extension Force at Week 8
Contralateral limb
|
122.1 lbs
Standard Deviation 23.8
|
105.8 lbs
Standard Deviation 51.0
|
PRIMARY outcome
Timeframe: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=4 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 9
Involved limb
|
82.3 lbs
Standard Deviation 49.5
|
65.1 lbs
Standard Deviation 21.0
|
|
Knee Extension Force at Week 9
Contralateral limb
|
119.6 lbs
Standard Deviation 40.0
|
111.0 lbs
Standard Deviation 40.2
|
PRIMARY outcome
Timeframe: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=2 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 10
Involved limb
|
83.1 lbs
Standard Deviation 45.9
|
57.0 lbs
Standard Deviation 10.4
|
|
Knee Extension Force at Week 10
Contralateral limb
|
118.4 lbs
Standard Deviation 42.9
|
80.0 lbs
Standard Deviation 31.2
|
PRIMARY outcome
Timeframe: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=4 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 11
Involved limb
|
81.2 lbs
Standard Deviation 33.3
|
41.8 lbs
Standard Deviation 3.5
|
|
Knee Extension Force at Week 11
Contralateral limb
|
112.6 lbs
Standard Deviation 28.3
|
92.8 lbs
Standard Deviation 39.1
|
PRIMARY outcome
Timeframe: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=6 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Knee Extension Force at Week 12
Involved limb
|
96.1 lbs
Standard Deviation 40.4
|
56 lbs
Standard Deviation 13.2
|
|
Knee Extension Force at Week 12
Contralateral limb
|
126.3 lbs
Standard Deviation 33.2
|
100.8 lbs
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=5 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 1
Involved limb
|
42.9 Centimeters
Standard Deviation 3.6
|
43.0 Centimeters
Standard Deviation 5.8
|
|
Thigh Circumference at Week 1
Contralateral limb
|
43.4 Centimeters
Standard Deviation 3.2
|
44.3 Centimeters
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 2
Involved limb
|
43.5 Centimeters
Standard Deviation 4.0
|
37.7 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 2
Contralateral limb
|
43.7 Centimeters
Standard Deviation 3.7
|
39.6 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 3
Involved limb
|
43.3 Centimeters
Standard Deviation 3.7
|
36.9 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 3
Contralateral limb
|
44.1 Centimeters
Standard Deviation 3.6
|
39.6 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 4
Involved limb
|
43.2 Centimeters
Standard Deviation 3.5
|
37 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 4
Contralateral limb
|
44.0 Centimeters
Standard Deviation 3.3
|
37.6 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=2 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 5
Involved limb
|
43.1 Centimeters
Standard Deviation 3.7
|
36.85 Centimeters
Standard Deviation 0.07
|
|
Thigh Circumference at Week 5
Contralateral limb
|
44.3 Centimeters
Standard Deviation 4.0
|
37.9 Centimeters
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=5 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 6
Involved limb
|
44.9 Centimeters
Standard Deviation 4.6
|
42.1 Centimeters
Standard Deviation 5.2
|
|
Thigh Circumference at Week 6
Contralateral limb
|
44.9 Centimeters
Standard Deviation 4.6
|
44.1 Centimeters
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=4 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 7
Involved limb
|
43.2 Centimeters
Standard Deviation 4.5
|
43.5 Centimeters
Standard Deviation 5.1
|
|
Thigh Circumference at Week 7
Contralateral limb
|
44.4 Centimeters
Standard Deviation 3.7
|
44.1 Centimeters
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=7 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 8
Involved limb
|
44.8 Centimeters
Standard Deviation 4.6
|
37.5 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 8
Contralateral limb
|
45.6 Centimeters
Standard Deviation 3.5
|
37.6 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 9
Involved limb
|
44.0 Centimeters
Standard Deviation 3.9
|
37.5 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 9
Contralateral limb
|
45.0 Centimeters
Standard Deviation 3.2
|
38.0 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 10
Involved limb
|
43.8 Centimeters
Standard Deviation 3.4
|
37.9 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 10
Contralateral limb
|
45.1 Centimeters
Standard Deviation 3.2
|
38.0 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=5 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 11
Involved limb
|
42.3 Centimeters
Standard Deviation 3.2
|
38.8 Centimeters
Data collected for one participant so there is no standard deviation
|
|
Thigh Circumference at Week 11
Contralateral limb
|
42.7 Centimeters
Standard Deviation 2.5
|
38.0 Centimeters
Data collected for one participant so there is no standard deviation
|
PRIMARY outcome
Timeframe: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)Population: Data collection was not completed at this timepoints for all participants
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Outcome measures
| Measure |
Blood Flow Restriction Group
n=6 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Thigh Circumference at Week 12
Involved limb
|
43.3 Centimeters
Standard Deviation 4.0
|
42.7 Centimeters
Standard Deviation 3.5
|
|
Thigh Circumference at Week 12
Contralateral limb
|
43.9 Centimeters
Standard Deviation 4.4
|
44.7 Centimeters
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)Population: Data collection was not completed at this timepoints for all participants
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Outcome measures
| Measure |
Blood Flow Restriction Group
n=2 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=5 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score at Week 6
|
24.7 score on a scale
Standard Deviation 0.81
|
37.0 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)Population: Data collection was not completed at this timepoints for all participants
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Outcome measures
| Measure |
Blood Flow Restriction Group
n=3 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=5 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score at Week 12
|
41.4 score on a scale
Standard Deviation 8.3
|
62.8 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)Population: Data collection was not completed at this timepoints for all participants
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Outcome measures
| Measure |
Blood Flow Restriction Group
n=2 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score at Week 24
|
75.3 score on a scale
Standard Deviation 12.2
|
59.8 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 3 months (performed at 3 months and 6 months post-operatively)Population: Data collection was not completed at this timepoints for all participants
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in centimeters in each direction) / (3\*limb length) \* 100.
Outcome measures
| Measure |
Blood Flow Restriction Group
n=2 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=1 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Y-balance Testing at Week 12
Contralateral limb
|
109.1 Percentage of limb length
Standard Deviation 11.0
|
102.6 Percentage of limb length
Data collected for one participant so there is no standard deviation
|
|
Y-balance Testing at Week 12
Involved limb
|
98.2 Percentage of limb length
Standard Deviation 6.6
|
95.4 Percentage of limb length
Data collected for one participant so there is no standard deviation
|
SECONDARY outcome
Timeframe: 6 months (performed at 3 months and 6 months post-operatively)Population: Data collection was not completed at this timepoints for all participants
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in centimeters in each direction) / (3\*limb length) \* 100.
Outcome measures
| Measure |
Blood Flow Restriction Group
n=1 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Y-balance Testing at Week 24
Involved limb
|
92.5 Percentage of limb length
Data collected for one participant so there is no standard deviation
|
96.8 Percentage of limb length
Standard Deviation 2.3
|
|
Y-balance Testing at Week 24
Contralateral limb
|
115.6 Percentage of limb length
Data collected for one participant so there is no standard deviation
|
101.3 Percentage of limb length
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 3 months (performed at 3 months and 6 months post-operatively)Population: This was not collected. We did not acquire this measurement on the subjects. We realized after initiating the study that this was too premature in the recovery to ask them to perform this task, and this was not done as a result.
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
Outcome measures
| Measure |
Blood Flow Restriction Group
This group underwent physical therapy with BFR intervention.
|
Control Group
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
3-hop Test at Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months (performed at 3 months and 6 months post-operatively)Population: Data was not collected for all patients.
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in meters.
Outcome measures
| Measure |
Blood Flow Restriction Group
n=1 Participants
This group underwent physical therapy with BFR intervention.
|
Control Group
n=3 Participants
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
3-hop Test at Week 24
Involved limb
|
4.8 Meters
Data collected for one participant so there is no standard deviation
|
3.3 Meters
Standard Deviation 1.7
|
|
3-hop Test at Week 24
Contralateral limb
|
5.7 Meters
Data collected for one participant so there is no standard deviation
|
3.4 Meters
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 3 months (performed at 3 months and 6 months post-operatively)Population: This outcome measure was not collected for any participants. While single-leg squat control at 12 and 24 weeks post-operatively was pre-specified in the protocol, the assessment was not implemented during physical therapy visits for any enrolled subjects due to logistical and operational challenges during study conduct. Consequently, no participants were assessed and no data were available for analysis or reporting for this outcome measure.
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation \& tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Outcome measures
| Measure |
Blood Flow Restriction Group
This group underwent physical therapy with BFR intervention.
|
Control Group
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Single Leg Squat Testing at Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months (performed at 3 months and 6 months post-operatively)Population: This outcome measure was not collected for any participants. While single-leg squat control at 12 and 24 weeks post-operatively was pre-specified in the protocol, the assessment was not implemented during physical therapy visits for any enrolled subjects due to logistical and operational challenges during study conduct. Consequently, no participants were assessed and no data were available for analysis or reporting for this outcome measure.
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation \& tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Outcome measures
| Measure |
Blood Flow Restriction Group
This group underwent physical therapy with BFR intervention.
|
Control Group
This group underwent standard-of-care physical therapy with sham BFR only.
|
|---|---|---|
|
Single Leg Squat Testing at Week 24
|
0 Participants
|
0 Participants
|
Adverse Events
Blood Flow Restriction Group
Control Group
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