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NCT Number: NCT05488054

Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

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.

Recruiting

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Key information

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Physical Therapy, Avon, Ohio, United States

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About this study

Patients with a diagnosis of ACL tear or hip pathology will undergo surgery. Following surgery, patients will report to clinic for scheduled physical therapy per their institution's injury-specific physical therapy protocol. At set time points (6-week, 12-week, 6 months, and 9 months) during their recovery, patients will be assessed for muscle oxygen saturation and hemoglobin levels with the Moxy sensor. This sensor is a non-invasive device placed over the rectus femoris to monitor oxygen and hemoglobin levels. The patient will then follow the therapy as instructed by the physical therapist and perform the protocol-specific exercises with the sensor in place. The measured parameters will be recorded and stored per patient.

The injured patients will be compared to healthy control patients undergoing a similar one-hour exercise session while wearing the Moxy sensor for comparison of results.

The goal of this study is to use the data obtained from the Moxy sensor device to further predict recovery of function in muscles supporting injured soft tissues to determine safe return to sport.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Study contacts

Contact information is provided by the study sponsor or research team.

James Voos, MD

CONTACT

[email protected]

216-844-0209

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Use of a Wearable Muscle Oxygen Saturation Sensor in the Rehabilitation of High-School and Collegiate Athletes Recovering From Arthroscopic Hip and Knee Surgery

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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