Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
Part of paid clinical trials in Avon, Ohio.
- Sponsor
- University Hospitals Cleveland Medical Center
- Study ID
- NCT05488054
- Status
- Recruiting
Conditions
- ACL Injury
- Hip Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 14 Years - 30 Years
- Healthy Volunteers
- Accepted
Interventions
- Physical Therapy — PROCEDUREPatients will undergo physical therapy following surgical intervention
- Monitored Work-out — PROCEDUREHealthy 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
Study Details
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.
Key Dates
- Start date
- Aug 8, 2022
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 226 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Healthy IndividualsHealthy control patients with no history of knee or hip surgery for comparison of baseline values
- Experimental: Surgical PatientsPatients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport
Primary Outcome Measure
Change in O2 Saturation levels as measured by Moxy Sensor device [ Time Frame: 6 months, 9 months, 12 months (once for healthy individuals) ]
Central Contacts
- James Voos, MD216-844-0209
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Hospitals Physical Therapy | Avon | Ohio | 44011 | Benjamin Geletka, PT 440-988-6890 |
| University Hospitals Cleveland Medial Center | Cleveland | Ohio | 44106 | James Voos, MD 216-844-0209 |
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