Anterior Cruciate Ligament TearNCT04374968
Use of Blood Flow Restriction Therapy Following ACL Tear
A study testing Blood flood restriction cuff in people with Anterior Cruciate Ligament Tear and Knee Injuries, run by Henry Ford Health System at 1 site in United States.
Trial summary
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury
- What is being tested?
- Blood flood restriction cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ACL tear undergoing reconstruction
Who cannot join
- History of pulmonary embolism
- History of deep vein thrombosis
- Family history of PE/DVT
- Hypercoaguable disorder
- Multiligamentous knee injury
- Neurovascular injury
Show all 9Show fewer
- Peripheral vascular disease
- Unable to complete physical therapy
- Unable to tolerate blood flow restriction
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital
West Bloomfield, Michigan, 48332
About this study
Official title: Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
Read the detailed description
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.
The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.
- Conditions
- Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury
- Being tested
- Blood flood restriction cuff
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flood restriction cuffDevice
Blood flow restriction cuffs will be used as an augment to physical therapy
| Study group | Role | What they receive |
|---|---|---|
| BFR Treatment | Experimental | Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR. Receives: Device: Blood flood restriction cuff |
| Control | No intervention | The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Strength in the Operative Leg
Quadriceps strength via handheld dynamometer. Quadriceps torque generation of operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV)
Measured: Change from Initial Clinic Visit to Pre-op
Secondary outcomes (3)
Patient Reported Outcome Measurement Information System
Patient reported outcomes measurement information system score on patient physical function.
PROMIS-PF: Assesses Activities of Daily Living and Capabilities. Below 30: Severe limitations, 30-40: Moderate limitations, 40-45: Mild limitations, Above 50: Greater than average physical function. Score scale (0-100) PROMIS-PI: Assesses Pain Indication. Below 55: Within normal limits of pain interference, 50-59: Mild interference, 60-69: Moderate interference, Above 70: Severe pain interference. Score scale (0-100) PROMIS-D: Measures Depressive symptoms: Below 55: Normal to slight symptoms, 55-59: Mild symptoms, 60-69: Moderate symptoms, Above 70: Severe depressive symptoms. Score scale (0-100)
Measured: Initial Clinic Visit
Participants Reporting Pain Using the Visual Analog Scale
Visual analog scale pain scores, scale 0-10 higher is more pain
Measured: Three months
Quadricep Strength in Non-operated Leg
Quadriceps torque generation of non-operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV)
Measured: Change from Initial Clinic Visit to Pre-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start28 Jul 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial with a treatment and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374968
- Sponsor's protocol ID
- 13080
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2020
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Okoroha KR, Tramer JS, Khalil LS, Jildeh TR, Abbas MJ, Buckley PJ, Lindell C, Moutzouros V. Effects of a Perioperative Blood Flow Restriction Therapy Program on Early Quadriceps Strength and Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 Nov 27;11(11):23259671231209694. doi: 10.1177/23259671231209694. eCollection 2023 Nov.
PubMed 38035216
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
- ClinicalTrials.gov ID
- NCT04374968
- Acronym / sponsor ID
- 13080
- Conditions
- Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
Detailed description
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.
The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial with a treatment and control group
| Arm | Type | Receives |
|---|---|---|
| BFR Treatment | Experimental | Device: Blood flood restriction cuffPatients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR. |
| Control | No intervention | –The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ACL tear undergoing reconstruction
Key exclusion criteria (9 listed)
- History of pulmonary embolism
- History of deep vein thrombosis
- Family history of PE/DVT
- Hypercoaguable disorder
- Multiligamentous knee injury
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 |
|---|---|---|
| Blood flood restriction cuffBlood flow restriction cuffs will be used as an augment to physical therapy | Device | BFR Treatment |
Primary outcome
Quadriceps Strength in the Operative Leg
Time frame: Change from Initial Clinic Visit to Pre-op
Quadriceps strength via handheld dynamometer. Quadriceps torque generation of operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV)
3 secondary outcomes
Patient Reported Outcome Measurement Information System
Time frame: Initial Clinic Visit
Participants Reporting Pain Using the Visual Analog Scale
Time frame: Three months
Quadricep Strength in Non-operated Leg
Time frame: Change from Initial Clinic Visit to Pre-Op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38035216Okoroha KR, Tramer JS, Khalil LS, Jildeh TR, Abbas MJ, Buckley PJ, Lindell C, Moutzouros V. Effects of a Perioperative Blood Flow Restriction Therapy Program on Early Quadriceps Strength and Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 Nov 27;11(11):23259671231209694. doi: 10.1177/23259671231209694. eCollection 2023 Nov.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flood restriction cuff in people with Anterior Cruciate Ligament Tear and Knee Injuries, run by Henry Ford Health System at 1 site 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Strength in the Operative Leg (time frame: Change from Initial Clinic Visit to Pre-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04374968, which also lists 1 linked publication.
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 3 Nov 2026.