Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of a Wearable Muscle Oxygen Saturation Sensor in the Rehabilitation of High-School and Collegiate Athletes Recovering From Arthroscopic Hip and Knee Surgery

Conditions
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ACL Injury, Hip Injuries

Intervention / Treatment
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* Procedure: Physical Therapy
* Procedure: Monitored Work-out
* Device: Moxy Oxygen Sensor Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: Patients age 14 to 30 years Patients with ACL injury requiring surgical correction Patients undergoing arthroscopic hip surgery Healthy individuals with no history of ACL, arthroscopic knee or arthroscopic hip surgery Exclusion Criteria: Patients below 14 years or above 30 years Non-English-speaking subjects Pregnant individuals

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Individuals<br>Healthy control patients with no history of knee or hip surgery for comparison of baseline values | Procedure: Monitored Work-out<br>* Healthy volunteers will undergo a monitored workout for comparison of data<br>Device: Moxy Oxygen Sensor Device<br>* Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles<br>|
| Experimental: Surgical Patients<br>Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport | Procedure: Physical Therapy<br>* Patients will undergo physical therapy following surgical intervention<br>Device: Moxy Oxygen Sensor Device<br>* Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |