Clinical trial NCT05488054: Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Injury
Hip Injuries
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 226
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in O2 Saturation levels as measured by Moxy Sensor device
timeFrame: 6 months, 9 months, 12 months (once for healthy individuals)
measure: Changes in hemoglobin levels as measured by Moxy Sensor device
timeFrame: 6 months, 9 months, 12 months (once for healthy individuals)
Secondary outcomes:
Other outcomes:
Locations:
city: Avon
country: United States
facility: University Hospitals Physical Therapy
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medial Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: James Voos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Sunita Mengers, MD
role: STUDY_DIRECTOR
References: