Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Hip Injuries; ACL Injury
• Intervention / Treatment: Procedure: Monitored Work-out; Device: Moxy Oxygen Sensor Device; Procedure: Physical Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Voos, MD; Phone Number: 216-844-0209; Email: james.voos@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Avon, Ohio, United States, 44011
      • Not yet recruiting
      • University Hospitals Physical Therapy
      • Contact: Benjamin Geletka, PT; Phone Number: 440-988-6890
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medial Center
      • Contact: James Voos, MD; Phone Number: 216-844-0209

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Individuals; Healthy control patients with no history of knee or hip surgery for comparison of baseline values	Procedure: Monitored Work-out; Healthy volunteers will undergo a monitored workout for comparison of data; Device: Moxy Oxygen Sensor Device; Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles
Experimental: Surgical Patients; Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport	Device: Moxy Oxygen Sensor Device; Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles; Procedure: Physical Therapy; Patients will undergo physical therapy following surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in O2 Saturation levels as measured by Moxy Sensor device	6 months, 9 months, 12 months (once for healthy individuals)
Changes in hemoglobin levels as measured by Moxy Sensor device	6 months, 9 months, 12 months (once for healthy individuals)

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: James Voos, MD, University Hospitals Cleveland Medical Center; Study Director: Sunita Mengers, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Hip Injuries; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: 20191389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No