Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

NCT05488054 | Recruiting FDA Device

• 1 other identifier: 20191389
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

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.

Conditions

ACL Injury; Hip Injuries

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Healthy Individuals

EXPERIMENTAL

Healthy control patients with no history of knee or hip surgery for comparison of baseline values

Procedure: Monitored Work-out; Device: Moxy Oxygen Sensor Device

Surgical Patients

EXPERIMENTAL

Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport

Procedure: Physical Therapy; Device: Moxy Oxygen Sensor Device

Interventions

Physical Therapy PROCEDURE

Patients will undergo physical therapy following surgical intervention

Surgical Patients

Monitored Work-out PROCEDURE

Healthy volunteers will undergo a monitored workout for comparison of data

Healthy Individuals

Moxy Oxygen Sensor Device DEVICE

Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles

Healthy Individuals; Surgical Patients

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients below 14 years or above 30 years
• Non-English-speaking subjects
• Pregnant individuals

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (2)

University Hospitals Physical Therapy

Avon, Ohio, 44011, United States

NOT YET RECRUITING

University Hospitals Cleveland Medial Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Hip Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• James Voos, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Sunita Mengers, MD

  University Hospitals Cleveland Medical Center

  STUDY DIRECTOR

Central Study Contacts

James Voos, MD

CONTACT

216-844-0209; james.voos@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Orthopaedic Surgery

Model Details: Patients will be enrolled in one of two arms: surgical patients undergoing physical therapy or healthy volunteers. Data from patients including O2 and hemoglobin levels in injured tissue will be collected to determine safe return to sport.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 8, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)