Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05488054

Conditions

ACL Injury

Hip Injuries

Eligibility Criteria

Sex: All

Age: 14 - 30

Healthy Volunteers: Accepted

Interventions

Physical Therapy

Monitored Work-out

Moxy Oxygen Sensor Device

Study Details

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.

Conditions

ACL Injury

Hip Injuries

Study ID

NCT05488054

Start date

Aug 8, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

226 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Physical Therapy

Patients will undergo physical therapy following surgical intervention

Monitored Work-out

Healthy volunteers will undergo a monitored workout for comparison of data

Moxy Oxygen Sensor Device

Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles

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) ]
  • Changes in hemoglobin levels as measured by Moxy Sensor device [ Time Frame: 6 months, 9 months, 12 months (once for healthy individuals) ]

Central Contacts and Locations

Central contacts

James Voos, MD

216-844-0209james.voos@UHhospitals.org

Locations

University Hospitals Cleveland Medial Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

James Voos, MD

216-844-0209

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-12-24.