Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

Not Applicable

Recruiting

• Conditions: ACL Injury; Hip Injuries
• Interventions: Procedure: Monitored Work-out; Procedure: Physical Therapy; Device: Moxy Oxygen Sensor Device

• Registration Number: NCT05488054
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

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 Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-08-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Patients	Moxy Oxygen Sensor Device	Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport
Healthy Individuals	Monitored Work-out	Healthy control patients with no history of knee or hip surgery for comparison of baseline values
Healthy Individuals	Moxy Oxygen Sensor Device	Healthy control patients with no history of knee or hip surgery for comparison of baseline values
Surgical Patients	Physical Therapy	Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

University Hospitals Physical Therapy; 🇺🇸 Avon, Ohio, United States

University Hospitals Cleveland Medial Center; 🇺🇸 Cleveland, Ohio, United States