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 — PROCEDURE
    Patients will undergo physical therapy following surgical intervention
  • Monitored Work-out — PROCEDURE
    Healthy volunteers will undergo a monitored workout for comparison of data
  • Moxy Oxygen Sensor Device — DEVICE
    Individuals 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 Individuals
    Healthy control patients with no history of knee or hip surgery for comparison of baseline values
  • Experimental: Surgical Patients
    Patients 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

Locations (2)

FacilityCityStateZIPSite coordinators
University Hospitals Physical TherapyAvonOhio44011
Benjamin Geletka, PT
440-988-6890
University Hospitals Cleveland Medial CenterClevelandOhio44106
James Voos, MD
216-844-0209

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