Study 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.
Eligible Conditions
- Anterior Cruciate Ligament Injury
- Hip Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 6 weeks, 12 weeks, 6 months, 9 months (once for healthy individuals)
Month 9
Change in O2 Saturation levels as measured by Moxy Sensor device
Changes in hemoglobin levels as measured by Moxy Sensor device
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Healthy Individuals
1 of 2
Surgical Patients
1 of 2
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Healthy Individuals · No Placebo Group · N/A
Healthy IndividualsExperimental Group · 2 Interventions: Monitored Work-out, Moxy Oxygen Sensor Device · Intervention Types: Procedure, Device
Surgical PatientsExperimental Group · 2 Interventions: Physical Therapy, Moxy Oxygen Sensor Device · Intervention Types: Procedure, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Therapy
2020
Completed Phase 4
~1330
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 12 weeks, 6 months, 9 months (once for healthy individuals)
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
300 Previous Clinical Trials
337,560 Total Patients Enrolled
James Voos, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Sunita Mengers, MDStudy DirectorUniversity Hospitals Cleveland Medical Center
Eligibility Criteria
Age 14 - 22 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for this study if you are age 14 to 22 years.
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Conditions
Cancer Related
Treatments