Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-30
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patients below 14 years or above 30 years
Non-English-speaking subjects
Pregnant individuals
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy
Procedure/SurgeryPatients will undergo physical therapy following surgical intervention
Monitored Work-out
Procedure/SurgeryHealthy volunteers will undergo a monitored workout for comparison of data
Moxy Oxygen Sensor Device
DeviceIndividuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: Healthy IndividualsExperimental treatment 2 interventions
Group B: Surgical PatientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in O2 Saturation levels as measured by Moxy Sensor device
Time frame
6 months, 9 months, 12 months (once for healthy individuals)2
Changes in hemoglobin levels as measured by Moxy Sensor device
Time frame
6 months, 9 months, 12 months (once for healthy individuals)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov