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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD093626-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Connecticut | OTHER |
| University of Delaware | OTHER |
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This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction. Improving muscle function may improve patient outcomes, improve joint mechanics, and potentially serve as a prevention approach for post-traumatic knee osteoarthritis. Knee osteoarthritis (OA) is a disabling disease that carries a substantial burden to society and to the individual affected.
Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in current understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. The investigators pilot work shows that when patients return to activity, quadriceps strength is ~70% of the uninjured side, which is far below the recommended 90%. Further, these data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as controlled trials with adequate sample sizes are currently lacking. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, the investigators propose a double-blind randomized controlled trial where ACLR patients will be randomized to 1 of 2 arms. Study arms will include: 1) 8 weeks of NMES+8 weeks of eccentric exercise; 2) 8 weeks of NMES placebo+8 weeks of eccentric placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. The investigators hypothesize that subjects receiving NMES+eccentric exercise (Arm 1) will realize greater improvements in strength and biomechanical function at 6 months following ACLR than patients in the placebo study arm. Further, the investigators anticipate that patients in the NMES+eccentric exercise arm (Arm 1) will best eliminate negative changes in cartilage health at 18 months following ACLR. This study is innovative, because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant because it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness which plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES+ECC | Experimental | Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions. |
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| NMES placebo + ECC placebo | Placebo Comparator | Neuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise low-intensity/placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Device | The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of at least 40& of the contralateral MVIC. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index | Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100 | Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction) |
| 9 Months Isokinetic Quadriceps Strength Limb Symmetry Index | Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100 | 9 months (9 months post-ACL reconstruction) |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Flexion Angle at 9 Months | Peak knee flexion angle of the ACL leg recorded during a single-legged hop (units: degrees) | 9 months post-ACL reconstruction |
| Knee Flexion Moment at 9 Months | Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedSport | Ann Arbor | Michigan | 48109 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32939539 | Derived | Rodriguez K, Garcia SA, Spino C, Lepley LK, Pang Y, Wojtys E, Bedi A, Angelini M, Ruffino B, Bolley T, Block C, Kellum J, Swartout A, Palmieri-Smith RM. Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial. Phys Ther. 2020 Dec 7;100(12):2154-2164. doi: 10.1093/ptj/pzaa169. |
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Participants were not randomized after enrollment for the following reasons:
A baseline testing session occurred prior to randomization.
Participants were recruited beginning in January of 2019 through July of 2023 from Michigan Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active High-Intensity NMES+ECC | Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive high-intensity NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning approximately 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 25, 2022 |
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| University of North Carolina, Chapel Hill |
| OTHER |
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| Eccentric Exercise (ECC) | Other | 4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum |
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| Neuromuscular Electrical Stimulation (NMES) placebo | Device | The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of 10-20% of the contralateral MVIC. |
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| Eccentric Exercise (ECC) placebo | Other | 4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum |
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| 9 months post-ACL reconstruction |
| Knee Flexion Angle at 18 Months | Peak knee flexion angle recorded during a single-legged hop (units: degrees) | 18 months post-ACL reconstruction |
| Knee Flexion Moment at 18 Months | Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m) | 18 months post-ACL reconstruction |
| T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage | [T1rho value at the weight bearing region of medial femur from MRI for ACL knee (msec)/T1rho value at the weight bearing region of medial femur for NonACL knee (msec)] x 100 | 18 months post-ACL reconstruction |
| T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage | [T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)] x 100 | 18 months post-ACL reconstruction |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| FG001 | Placebo Low-Intensity NMES + ECC | Neuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise low-intensity/placebo, patients will begin to receive low dose eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions. |
| Post-NMES Intervention Testing |
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| Post-ECC Intervention Testing |
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| 9 month post-ACLR testing |
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| 18 month post-ACLR testing |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NMES+ECC | Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions. |
| BG001 | NMES Placebo + ECC Placebo | Neuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise low-intensity/placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index | Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100 | Active High-Intensity NMES + ECC: 2 subjects withdrawn by investigator, 0 subjects lost to follow up, 1 subject withdrew consent, 2 people missing strength data Placebo Low-Intensity NMES + ECC: 1 subjects withdrawn by investigator, 2 subjects lost to follow up, 2 subject withdrew consent, 1 person missing strength data | Posted | Mean | Standard Deviation | Percentage | Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction) |
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| Primary | 9 Months Isokinetic Quadriceps Strength Limb Symmetry Index | Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100 | Active High-Intensity NMES + ECC: 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent | Posted | Mean | Standard Deviation | Percentage | 9 months (9 months post-ACL reconstruction) |
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| Secondary | Knee Flexion Angle at 9 Months | Peak knee flexion angle of the ACL leg recorded during a single-legged hop (units: degrees) | Active High-Intensity NMES + ECC : 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent, 16 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent, 10 subjects could not complete a single leg hop so data is missing | Posted | Mean | Standard Deviation | Degrees | 9 months post-ACL reconstruction |
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| Secondary | Knee Flexion Moment at 9 Months | Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m) | Active High-Intensity NMES + ECC: 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent, 16 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent, 10 subjects could not complete a single leg hop so data is missing | Posted | Mean | Standard Deviation | Nm/kg*m | 9 months post-ACL reconstruction |
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| Secondary | Knee Flexion Angle at 18 Months | Peak knee flexion angle recorded during a single-legged hop (units: degrees) | Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subjects withdrew consent, 7 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 10 subjects lost to follow up, 2 subjects withdrew consent, 6 subjects could not complete a single leg hop so data is missing | Posted | Mean | Standard Deviation | Degrees | 18 months post-ACL reconstruction |
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| Secondary | Knee Flexion Moment at 18 Months | Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m) | Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 7 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 10 subjects lost to follow up, 2 subject withdrew consent, 6 subjects could not complete a single leg hop so data is missing | Posted | Mean | Standard Deviation | Nm/kg*m | 18 months post-ACL reconstruction |
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| Secondary | T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage | [T1rho value at the weight bearing region of medial femur from MRI for ACL knee (msec)/T1rho value at the weight bearing region of medial femur for NonACL knee (msec)] x 100 | Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 1 person with MRI scan error so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 11 subjects lost to follow up, 2 subject withdrew consent | Posted | Mean | Standard Deviation | Percentage | 18 months post-ACL reconstruction |
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| Secondary | T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage | [T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)] x 100 | NMES+ECC arm: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 1 person with MRI scan error so data is missing NMES placebo + ECC placebo arm: 7 subjects withdrawn by investigator, 11 subjects lost to follow up, 2 subject withdrew consent | Posted | Mean | Standard Deviation | Percentage | 18 months post-ACL reconstruction |
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From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
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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 | NMES+ECC | Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions. | 0 | 57 | 8 | 57 | 2 | 57 |
| EG001 | NMES Placebo + ECC Placebo | Neuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise low-intensity/placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions. | 0 | 56 | 6 | 56 | 3 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Surgical and medical procedures | MeDRA | Non-systematic Assessment | Unrelated to intervention |
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| Accidental Overdose | Injury, poisoning and procedural complications | MeDRA | Non-systematic Assessment | Unrelated to Intervention |
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| Septoplasty | Surgical and medical procedures | MeDRA | Non-systematic Assessment | Unrelated to Intervention |
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| Loss of Consciousness | Nervous system disorders | MeDRA | Non-systematic Assessment | Unrelated to Intervention |
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| Hospitalization for severe persistent asthma w/ exacerbation | Respiratory, thoracic and mediastinal disorders | MeDRA | Non-systematic Assessment | Unrelated to Intervention |
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| Meniscal Surgery | Surgical and medical procedures | MeDRA | Non-systematic Assessment | Unrelated to Intervention |
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| Cyclops lesion excision | Surgical and medical procedures | MeDRA | Non-systematic Assessment | Unrelated to intervention |
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| Anterolateral Ligament Reconstruction with partial ACL graft tear | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment |
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| Contralateral ACL tear | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment | Not related to the intervention |
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| Knee arthroscopy | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment | Not related to the intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACL graft tear that was not reconstructed | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment | Not related to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Riann Palmieri-Smith, PhD, ATC | University of Michigan | 734-615-3154 | riannp@umich.edu |
| Nov 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Nov 18, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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