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Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

Primary Purpose

ACL Injury, Hip Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Monitored Work-out
Moxy Oxygen Sensor Device
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age range: Patients age 14 to 22 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 22 years
  • Non-English-speaking subjects
  • Pregnant individuals

Sites / Locations

  • University Hospitals Physical Therapy
  • University Hospitals Cleveland Medial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Individuals

Surgical Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in O2 Saturation levels as measured by Moxy Sensor device
Changes in hemoglobin levels as measured by Moxy Sensor device

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
November 11, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05488054
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Hip Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Individuals
Arm Type
Experimental
Arm Description
Healthy control patients with no history of knee or hip surgery for comparison of baseline values
Arm Title
Surgical Patients
Arm Type
Experimental
Arm Description
Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Patients will undergo physical therapy following surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Monitored Work-out
Intervention Description
Healthy volunteers will undergo a monitored workout for comparison of data
Intervention Type
Device
Intervention Name(s)
Moxy Oxygen Sensor Device
Intervention Description
Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles
Primary Outcome Measure Information:
Title
Change in O2 Saturation levels as measured by Moxy Sensor device
Time Frame
6 weeks, 12 weeks, 6 months, 9 months (once for healthy individuals)
Title
Changes in hemoglobin levels as measured by Moxy Sensor device
Time Frame
6 weeks, 12 weeks, 6 months, 9 months (once for healthy individuals)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range: Patients age 14 to 22 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 22 years Non-English-speaking subjects Pregnant individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Voos, MD
Phone
216-844-0209
Email
james.voos@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Voos, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunita Mengers, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals Physical Therapy
City
Avon
State/Province
Ohio
ZIP/Postal Code
44011
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Geletka, PT
Phone
440-988-6890
Facility Name
University Hospitals Cleveland Medial Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Voos, MD
Phone
216-844-0209

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

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