Knee InjuriesNCT04528992
Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation
A study testing Blood Flow Restriction Therapy and Standard Postoperative Physical Therapy in people with Knee Injuries and Anterior Cruciate Ligament Injuries, run by Stanford University at 1 site in United States.
Trial summary
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries, Anterior Cruciate Ligament Injuries
- What is being tested?
- Blood Flow Restriction Therapy and Standard Postoperative Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 or older, all gender
- Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue
Who cannot join
- Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
- Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- Revision procedures
- Patients unable to lay still in an MRI scanner
- Patients receiving treatment outside Stanford
- Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol
- Patients who are unable to lay still in an MRI scanner
- Patients with a torn ACL or previous ACL reconstruction in the contralateral knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
Read the detailed description
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.
To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
- Conditions
- Knee Injuries, Anterior Cruciate Ligament Injuries
- Being tested
- Blood Flow Restriction Therapy, Standard Postoperative Physical Therapy
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TherapyOther
BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.
Standard Postoperative Physical TherapyOther
This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy with BFR | Experimental | Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol. Receives: Other: Blood Flow Restriction Therapy |
| Physical Therapy without BFR | Active comparator | Participants will undergo standard physical therapy following the surgeon's postoperative protocol. Receives: Other: Standard Postoperative Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in MRI imaging of Graft
Graft ligamentization or maturation on MRI using T2 mapping
Measured: 2 weeks, 3 months, 6 months
Difference in Quadriceps Volume & Cross-sectional Area
Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area
Measured: 3 months, 6 months
Difference in Thigh Circumference Measurement
Muscle measurement determined with measuring tape for thigh circumference
Measured: 3 months, 6 months
Secondary outcomes (4)
Isokinetic Dynamometer
Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer
Measured: 2 weeks, 3 months, 6 months
Visual Analog Scale (VAS)
Patient reported assessment of current level of pain from no pain to worst imaginable
Measured: 2 weeks, 3 months, 6 months
Single Assessment Numerical Evaluation (SANE)
Patient reported outcome measure of function. 0-100% scale with 100% being normal
Measured: 2 weeks, 3 months, 6 months
International Knee Documentation Committee (IKDC)
Patient reported outcome measure of symptoms, sports activity \& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: 2 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start20 Sep 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Why it stopped: BFR Physical Therapy Protocol was not finalized and department had multiple similar studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Sherman, Stanford University
- Investigators
- Seth Sherman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528992
- Sponsor's protocol ID
- IRB-56716
- Status last verified
- Nov 2024
- First submitted
- 18 Aug 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
- ClinicalTrials.gov ID
- NCT04528992
- Acronym / sponsor ID
- IRB-56716
- Conditions
- Knee Injuries, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: BFR Physical Therapy Protocol was not finalized and department had multiple similar studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 27 Aug 2020 (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 is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
Detailed description
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.
To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy with BFR | Experimental | Other: Blood Flow Restriction TherapyParticipants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol. |
| Physical Therapy without BFR | Active comparator | Other: Standard Postoperative Physical TherapyParticipants will undergo standard physical therapy following the surgeon's postoperative protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 or older, all gender
- Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue
Key exclusion criteria (8 listed)
- Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
- Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- Revision procedures
- Patients unable to lay still in an MRI scanner
- Patients receiving treatment outside Stanford
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 Flow Restriction TherapyBFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery. | Other | Physical Therapy with BFR |
| Standard Postoperative Physical TherapyThis is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction. | Other | Physical Therapy without BFR |
Primary outcome
Difference in MRI imaging of Graft
Time frame: 2 weeks, 3 months, 6 months
Graft ligamentization or maturation on MRI using T2 mapping
Difference in Quadriceps Volume & Cross-sectional Area
Time frame: 3 months, 6 months
Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area
Difference in Thigh Circumference Measurement
Time frame: 3 months, 6 months
Muscle measurement determined with measuring tape for thigh circumference
4 secondary outcomes
Isokinetic Dynamometer
Time frame: 2 weeks, 3 months, 6 months
Visual Analog Scale (VAS)
Time frame: 2 weeks, 3 months, 6 months
Single Assessment Numerical Evaluation (SANE)
Time frame: 2 weeks, 3 months, 6 months
International Knee Documentation Committee (IKDC)
Time frame: 2 weeks, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Seth Sherman, MD principal investigator
Stanford University
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 Flow Restriction Therapy and Standard Postoperative Physical Therapy in people with Knee Injuries and Anterior Cruciate Ligament Injuries, run by Stanford University 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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 25 Nov 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in MRI imaging of Graft (time frame: 2 weeks, 3 months, 6 months). The study lists 3 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 25 Nov 2024.