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We had difficulty with enrolling enough participants. We looked to include patients undergoing isolated meniscus repair surgery doing PT with our group and this group proved to be too small to enroll enough patients.
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The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
The investigators will conduct a double-blinded, single-institution, randomized controlled trial to compare patients undergoing arthroscopic meniscus repair with post-operative rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative extremity versus (2) blood flow restriction training with cuff occlusion applied to the operative extremity. Patients will be enrolled prospectively and pre-operatively at their initial clinic visit after meniscus injury.
Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood flow restriction | Experimental | 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. |
|
| Standard rehabilitation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction (Delfi Personalized Tourniquet System) | Device | The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extension Force at Week 1 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 2 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 3 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 4 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 5 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 6 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 7 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score at Week 6 | 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 | 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Allahabadi, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Flow Restriction Group | This group underwent physical therapy with BFR intervention. |
| FG001 | Control Group | This group underwent standard-of-care physical therapy with sham BFR only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Flow Restriction | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Extension Force at Week 1 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Posted | Mean | Standard Deviation | lbs | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
6 months
The definition of adverse events used does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Flow Restriction Group | This group underwent physical therapy with BFR intervention. |
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We had a difficult time enrolling subjects. Subjects could be included if they had an isolated meniscus tear and were doing physical therapy at our university-based PT practice. Many of our patients had associated injuries (ACL tear, etc) that were disqualifying. We excluded meniscus root tears or radial tears that required different rehab plans. We are a tertiary/quaternary referral center and many patients live farther away, so in-person PT was not possible at our location.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drew Lansdown | University of California, San Francisco | 415-353-8208 | drew.lansdown@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2023 | Jan 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070600 | Tibial Meniscus Injuries |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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|
| Standard rehabilitation | Other | Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair. |
|
| Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 8 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 9 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 10 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 11 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Knee Extension Force at Week 12 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 1 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 2 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 3 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 4 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 5 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 6 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 7 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 8 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 9 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 10 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 11 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| Thigh Circumference at Week 12 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
| International Knee Documentation Committee (IKDC) Score at Week 12 |
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 |
| 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively) |
| International Knee Documentation Committee (IKDC) Score at Week 24 | 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 | 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) |
| Y-balance Testing at Week 12 | 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. | 3 months (performed at 3 months and 6 months post-operatively) |
| Y-balance Testing at Week 24 | 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. | 6 months (performed at 3 months and 6 months post-operatively) |
| 3-hop Test at Week 12 | 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. | 3 months (performed at 3 months and 6 months post-operatively) |
| 3-hop Test at Week 24 | 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. | 6 months (performed at 3 months and 6 months post-operatively) |
| Single Leg Squat Testing at Week 12 | 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 | 3 months (performed at 3 months and 6 months post-operatively) |
| Single Leg Squat Testing at Week 24 | 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 | 6 months (performed at 3 months and 6 months post-operatively) |
| BG001 | Standard Rehabilitation | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Knee Extension Force at Week 2 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 3 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 4 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 5 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 6 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Posted | Mean | Standard Deviation | lbs | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 7 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 8 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 9 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 10 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 11 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Knee Extension Force at Week 12 | Peak knee extension force (lbs) evaluated with a hand-held dynamometer | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | lbs | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 1 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 2 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 3 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 4 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 5 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 6 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 7 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 8 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 9 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 10 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 11 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Primary | Thigh Circumference at Week 12 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Centimeters | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) |
|
|
|
| Secondary | International Knee Documentation Committee (IKDC) Score at Week 6 | 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 | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) |
|
|
|
| Secondary | International Knee Documentation Committee (IKDC) Score at Week 12 | 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 | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | score on a scale | 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively) |
|
|
|
| Secondary | International Knee Documentation Committee (IKDC) Score at Week 24 | 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 | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | score on a scale | 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) |
|
|
|
| Secondary | Y-balance Testing at Week 12 | 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. | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Percentage of limb length | 3 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| Secondary | Y-balance Testing at Week 24 | 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. | Data collection was not completed at this timepoints for all participants | Posted | Mean | Standard Deviation | Percentage of limb length | 6 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| Secondary | 3-hop Test at Week 12 | 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. | 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. | Posted | Count of Participants | Participants | 3 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| Secondary | 3-hop Test at Week 24 | 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. | Data was not collected for all patients. | Posted | Mean | Standard Deviation | Meters | 6 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| Secondary | Single Leg Squat Testing at Week 12 | 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 | 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. | Posted | Count of Participants | Participants | 3 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| Secondary | Single Leg Squat Testing at Week 24 | 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 | 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. | Posted | Count of Participants | Participants | 6 months (performed at 3 months and 6 months post-operatively) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control Group | This group underwent standard-of-care physical therapy with sham BFR only. | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |