Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

ACL Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488054
• Other study ID #: 20191389
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: James Voos, MD
• Phone: 216-844-0209
• Email: james.voos[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Hip Injuries
• Wounds and Injuries

Intervention

Procedure:
• Physical Therapy
Patients will undergo physical therapy following surgical intervention
• 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

Locations

Country	Name	City	State
United States	University Hospitals Physical Therapy	Avon	Ohio
United States	University Hospitals Cleveland Medial Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in O2 Saturation levels as measured by Moxy Sensor device		6 months, 9 months, 12 months (once for healthy individuals)
Primary	Changes in hemoglobin levels as measured by Moxy Sensor device		6 months, 9 months, 12 months (once for healthy individuals)