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Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

NCT ID: NCT05488054

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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ACL Injury Hip Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Individuals

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

Group Type EXPERIMENTAL

Monitored Work-out

Intervention Type PROCEDURE

Healthy volunteers will undergo a monitored workout for comparison of data

Moxy Oxygen Sensor Device

Intervention Type DEVICE

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

Surgical Patients

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

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type PROCEDURE

Patients will undergo physical therapy following surgical intervention

Moxy Oxygen Sensor Device

Intervention Type DEVICE

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

Interventions

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Physical Therapy

Patients will undergo physical therapy following surgical intervention

Intervention Type PROCEDURE

Monitored Work-out

Healthy volunteers will undergo a monitored workout for comparison of data

Intervention Type PROCEDURE

Moxy Oxygen Sensor Device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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James E Voos, MD

Chairman, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Voos, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Sunita Mengers, MD

Role: STUDY_DIRECTOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Physical Therapy

Avon, Ohio, United States

Site Status NOT_YET_RECRUITING

University Hospitals Cleveland Medial Center

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Voos, MD

Role: CONTACT

Phone: 216-844-0209

Email: [email protected]

Facility Contacts

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Benjamin Geletka, PT

Role: primary

James Voos, MD

Role: primary

Other Identifiers

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20191389

Identifier Type: -

Identifier Source: org_study_id