ACL Injury, Hip Injuries
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPhysical Therapy
Patients will undergo physical therapy following surgical intervention
PROCEDUREMonitored Work-out
Healthy volunteers will undergo a monitored workout for comparison of data
DEVICEMoxy Oxygen Sensor Device
Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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) |
Countries
United States
Contacts
Primary ContactJames Voos, MD
Outcome results
None listed