NCT05488054

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 14 Years – 30 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• ACL Injury
• Hip Injuries

Interventions

Type	Name	Description
PROCEDURE	Physical Therapy	Patients will undergo physical therapy following surgical intervention
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

Timeline

• Start date: 2022-08-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-08-04
• Last updated: 2025-12-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study