ACL InjuryNCT05488054
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
A study testing Physical Therapy, Monitored Work-out and Moxy Oxygen Sensor Device in people with ACL Injury and Hip Injuries, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, Hip Injuries
- What is being tested?
- Physical Therapy, Monitored Work-out and Moxy Oxygen Sensor Device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients below 14 years or above 30 years
- Non-English-speaking subjects
- Pregnant individuals
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University Hospitals Physical Therapy
Avon, Ohio, 44011
Benjamin Geletka, PT, 440-988-6890
- Recruiting
University Hospitals Cleveland Medial Center
Cleveland, Ohio, 44106
James Voos, MD, 216-844-0209
About this study
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
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.
Read the 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.
- Conditions
- ACL Injury, Hip Injuries
- Being tested
- Physical Therapy, Monitored Work-out, Moxy Oxygen Sensor Device
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
Patients will undergo physical therapy following surgical intervention
Monitored Work-outProcedure or surgery
Healthy volunteers will undergo a monitored workout for comparison of data
Moxy Oxygen Sensor DeviceDevice
Individuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Experimental | Healthy control patients with no history of knee or hip surgery for comparison of baseline values Receives: 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 Receives: Procedure: Physical Therapy; Device: Moxy Oxygen Sensor Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in O2 Saturation levels as measured by Moxy Sensor device
Measured: 6 months, 9 months, 12 months (once for healthy individuals)
Changes in hemoglobin levels as measured by Moxy Sensor device
Measured: 6 months, 9 months, 12 months (once for healthy individuals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start8 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James E Voos, MD, University Hospitals Cleveland Medical Center
- Investigators
- James Voos, MD, Principal investigator, University Hospitals Cleveland Medical CenterSunita Mengers, MD, Study director, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488054
- Sponsor's protocol ID
- 20191389
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05488054
- Acronym / sponsor ID
- 20191389
- Conditions
- ACL Injury, Hip Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | Experimental | Procedure: Monitored Work-out, Device: Moxy Oxygen Sensor DeviceHealthy control patients with no history of knee or hip surgery for comparison of baseline values |
| Surgical Patients | Experimental | Procedure: Physical Therapy, Device: Moxy Oxygen Sensor DevicePatients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients below 14 years or above 30 years
- Non-English-speaking subjects
- Pregnant individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyPatients will undergo physical therapy following surgical intervention | Procedure or surgery | Surgical Patients |
| Monitored Work-outHealthy volunteers will undergo a monitored workout for comparison of data | Procedure or surgery | Healthy Individuals |
| Moxy Oxygen Sensor DeviceIndividuals will wear a Moxy sensor device during workouts to monitor oxygen and hemoglobin levels in their muscles | Device | Healthy Individuals, Surgical Patients |
Primary outcome
Change in O2 Saturation levels as measured by Moxy Sensor device
Time frame: 6 months, 9 months, 12 months (once for healthy individuals)
Changes in hemoglobin levels as measured by Moxy Sensor device
Time frame: 6 months, 9 months, 12 months (once for healthy individuals)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Voos, MD principal investigator
University Hospitals Cleveland Medical Center
Sunita Mengers, MD study director
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy, Monitored Work-out and Moxy Oxygen Sensor Device in people with ACL Injury and Hip Injuries, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Voos, MD (216-844-0209, james.voos@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in O2 Saturation levels as measured by Moxy Sensor device (time frame: 6 months, 9 months, 12 months (once for healthy individuals)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.