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This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.
Patients with a diagnosis of ACL tear or hip pathology will undergo surgery. Following surgery, patients will report to clinic for scheduled physical therapy per their institution's injury-specific physical therapy protocol. At set time points (6-week, 12-week, 6 months, and 9 months) during their recovery, patients will be assessed for muscle oxygen saturation and hemoglobin levels with the Moxy sensor. This sensor is a non-invasive device placed over the rectus femoris to monitor oxygen and hemoglobin levels. The patient will then follow the therapy as instructed by the physical therapist and perform the protocol-specific exercises with the sensor in place. The measured parameters will be recorded and stored per patient.
The injured patients will be compared to healthy control patients undergoing a similar one-hour exercise session while wearing the Moxy sensor for comparison of results.
The goal of this study is to use the data obtained from the Moxy sensor device to further predict recovery of function in muscles supporting injured soft tissues to determine safe return to sport.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Individuals | Experimental | Healthy control patients with no history of knee or hip surgery for comparison of baseline values |
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| Surgical Patients | Experimental | Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Procedure | Patients will undergo physical therapy following surgical intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in O2 Saturation levels as measured by Moxy Sensor device | 6 months, 9 months, 12 months (once for healthy individuals) | |
| Changes in hemoglobin levels as measured by Moxy Sensor device | 6 months, 9 months, 12 months (once for healthy individuals) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Voos, MD | Contact | 216-844-0209 | james.voos@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| James Voos, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Sunita Mengers, MD | University Hospitals Cleveland Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Physical Therapy | Not yet recruiting | Avon | Ohio | 44011 | United States |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Patients will be enrolled in one of two arms: surgical patients undergoing physical therapy or healthy volunteers. Data from patients including O2 and hemoglobin levels in injured tissue will be collected to determine safe return to sport.
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| Monitored Work-out | Procedure | Healthy volunteers will undergo a monitored workout for comparison of data |
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| Moxy Oxygen Sensor Device | Device | Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles |
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| University Hospitals Cleveland Medial Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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