ACL InjuryNCT04519801
BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
A study testing Blood Flow Restriction (BFR) therapy and Standard REHAB in people with ACL Injury, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Blood Flow Restriction (BFR) therapy and Standard REHAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 1 Mar 2026
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Active duty member or Department of Defense Military Health System beneficiary
- 15 to 45 years of age
- Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates
Who cannot join
- Patients undergoing a concomitant surgical procedure that would otherwise require a period of immobilization and/or restricted weight bearing (i.e. meniscal repair, meniscal allograft transplantation, osteochondral allograft transplantation, high tibial osteotomy) will be excluded.
- Undergoing combined multiligamentous knee injury reconstruction
- Unable to consistently participate in the prescribed post-operative rehabilitation regimen
- No patients with a history of recent lower extremity deep vein thrombosis, within the 12 months or on active treatment with anticoagulants, a history of ipsilateral lower extremity lymph node dissection or a history of endothelial dysfunction.
- Patients that are unable to obtain MRI secondary to either intolerance and/or implanted medical devices that preclude the safe completion of the MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center- Clinical Research Center
San Antonio, Texas, 78234
About this study
Official title: Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 16 weeks, and at 56 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 28 weeks, 40 weeks, and 56 weeks post-operative (secondary outcome measures).
Read the detailed description
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following ACLR standardized with respect to both surgical technique and graft selection. The investigator's central hypothesis is that the addition of BFR therapy has the potential to accelerate surgical recovery, expedite return-to-duty, and maximize medical readiness following ACLR. In the proposed trial validated isokinetic and isometric quadriceps strength testing will be used to quantify the effect of therapy on quadriceps strength, patient reported outcome measures will be used to assess for functional clinical improvement, while quadriceps musculature volume as measured on MRI will be used as an effort independent measure of quadriceps recovery. The rationale for using this modality is based upon the fact that the measurement of quadriceps CSA and muscle volume as surrogates for overall quadriceps function is well described, and a number of studies have convincingly demonstrated positive correlations between these parameters and quadriceps strength4, 17. However, in spite of these reports, the acceptance acknowledging MRI as a surrogate for quadriceps strength remains limited. Therefore, isokinetic and isometric quadriceps strength of both the operative and non-operative knee extensors (quadriceps) will be measured pre-operatively within 7-10 days approximately prior to ACLR and post-operatively at approximately 16 weeks, 28 weeks, 40 weeks, and 56 weeks. MRI of bilateral thighs will be performed immediately prior to ACLR to establish a baseline CSA in the operative and non-operative lower extremity. Then a repeat MRI will be performed following the conclusion of a standardized 12-week (approximately) post-operative rehabilitation regimen among patients randomized to either a standard rehabilitation regimen (REHAB) or a rehabilitation regimen with BFR (REHAB + BFR.) Finally, MRI will be repeated at 56 weeks post-operative to examine for latent changes in CSA once patients have been returned to unrestricted physical activities.
AIM 1: To determine if the addition of BFR therapy to a standard post-operative rehabilitation protocol increases functional strength and quadriceps muscle volume as measured with magnetic resonance imaging (MRI) after ACLR.
Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will increase quadriceps strength and muscle volume when compared to a standard post-operative rehabilitation regimen measured at approximately 16-weeks post-operative.
AIM 2: To determine if any observed increases in quadriceps strength and muscle volume are sustained beyond the cessation of BFR therapy at approximately 56 weeks post-operative.
Hypothesis: Observed increases in quadriceps strength and muscle volume will be sustained beyond the cessation of BFR therapy at 56 weeks post-operative.
AIM 3: To determine if CSA measurements obtained by MRI reliably predict knee extensor strength.
Hypothesis: CSA measurements obtained by MRI reliably predict knee extensor strength as measured by isokinetic and isometric testing.
AIM 4: To determine if the addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR results in significantly improved functional outcomes when compared to a standard post-operative rehabilitation regimen at 28, 40, and 56 weeks post-operative using patient reported outcomes (PRO).
Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will result in significantly improved PRO when compared to a standard post-operative rehabilitation regimen at 28, 40, and 56-weeks post-operative.
- Conditions
- ACL Injury
- Being tested
- Blood Flow Restriction (BFR) therapy, Standard REHAB
- Keywords
- BFR, ACLR, Quadriceps Tendon
- Medical subject headings
- 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 (BFR) therapyOther
BFR therapy beginning after first MD follow up appointment after ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion.
Standard REHABOther
Standard post-operative rehabilitation regimen (REHAB) beginning after first MD follow up appointment ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion
| Study group | Role | What they receive |
|---|---|---|
| REHAB | Other | Standard post-operative rehabilitation regimen (REHAB) (Control) Receives: Other: Standard REHAB |
| REHAB + BFR | Experimental | Standard rehabilitation regimen with BFR therapy (REHAB + BFR) (Experimental) Receives: Other: Blood Flow Restriction (BFR) therapy; Other: Standard REHAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensor strength
Knee extensor isokinetic and isometric strength measurements
Measured: [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 16 weeks post operatively] [Time Frame: 28 weeks post-operatively] [Time Frame: 40 weeks post-operatively] [Time Frame: 56 weeks post-operatively]
Secondary outcomes (7)
Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS)
The VAS is a unidimensional measure of pain intensity that has been frequently reported among adults. The simplest VAS is represented as a horizontal 10 cm line. The ends are defined as the extreme limits of parameter being measured (e.g. pain) oriented from the left (worst) to the right (best.) Patients are asked mark their perceived level of pain on the horizontal line. The VAS score is determined by measuring in mm from the left hand end of the horizontal line to where the patient marks. A higher score represents greater pain intensity.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - Lysholms Score
Comprised of 8 items (limp, support, locking, instability, pain, swelling, stair climbing, squatting), which patients are asked a series of questions to characterize their experiences with respect to each of these 8 items. Patients' responses are summed, with a score of 100 denoting no symptoms or debility.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)
This questionnaire is broken down into three categories: symptoms, sports activity, and knee function. The symptoms subscale focuses on an assessment of pain, stiffness, swelling, and the sensation of "giving-way" of the knee. The sports activity subscale focuses on completion of tasks such as going up and down stairs, rising from a seated position, squatting, and jumping. The knee function subscale asks the respondent to characterize their knee at present versus prior to injury. The IKDC is scored out of 100 points, with a score of 100 representing optimal knee function.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive scoring system that evaluates both short and long-term consequence of knee injury. It is comprised of 42 items, which are scored separately in 5 subscales (pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee-related quality of life (5 items).) Among the strengths of the KOOS as a PRO is its inclusion of two different subscales for physical function relating to daily life, sport, and recreation. A score of 100 represents no knee symptoms, which is then converted to a percentage score to characterize a patient's overall satisfaction with their knee function.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Connor-Davidson Resilience Scale (CD-RISC)
The CD- RISC 2, 10, or 25 item validated instrument that is self-rated assessment of psychological resiliency. This instrument has shown reliability in measuring the ability to adapt to change, the ability to deal with what comes along, the ability to cope with stress, the ability to stay focused and think clearly, the ability to not get discouraged in the face of failure, the ability to handle unpleasant feelings such as anger, pain or sadness.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) (Short version 6Q)
ACL-RSI instrument measure one's emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. The survey consists of 12 items that are graded on a visual analogue scale from 0 points (extremely negative psychological responses) to 100 points (no negative psychological responses). The results of the survey have been found to be strongly and significantly associated with return to sport.
Measured: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Quadriceps volume
Quadriceps volume as measured on MRI
Measured: [Timeframe: within 7-10 days of ACLR] [Time Frame: approximately 16 weeks post operative] [Time Frame: approximately 56 weeks post-operative]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start9 Sep 2022
- Primary completion13 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- 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
- Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- American Orthopaedic Society for Sports Medicine, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Daniel Cognetti, Brooke Army Medical Center
- Investigators
- Andrew J Sheean, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519801
- Sponsor's protocol ID
- C.2020.053
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
PubMed 26920430Goetschius J, Hart JM. Knee-Extension Torque Variability and Subjective Knee Function in Patients with a History of Anterior Cruciate Ligament Reconstruction. J Athl Train. 2016 Jan;51(1):22-7. doi: 10.4085/1062-6050-51.1.12. Epub 2015 Dec 31.
PubMed 26720104Zwolski C, Schmitt LC, Quatman-Yates C, Thomas S, Hewett TE, Paterno MV. The influence of quadriceps strength asymmetry on patient-reported function at time of return to sport after anterior cruciate ligament reconstruction. Am J Sports Med. 2015 Sep;43(9):2242-9. doi: 10.1177/0363546515591258. Epub 2015 Jul 16.
PubMed 26183172Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
PubMed 25683732Kuenze C, Hertel J, Saliba S, Diduch DR, Weltman A, Hart JM. Clinical thresholds for quadriceps assessment after anterior cruciate ligament reconstruction. J Sport Rehabil. 2015 Feb;24(1):36-46. doi: 10.1123/jsr.2013-0110. Epub 2014 Sep 8.
PubMed 25203517Johnston PT, McClelland JA, Webster KE. Lower Limb Biomechanics During Single-Leg Landings Following Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Sep;48(9):2103-2126. doi: 10.1007/s40279-018-0942-0.
PubMed 29949109Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Burgomaster KA, Moore DR, Schofield LM, Phillips SM, Sale DG, Gibala MJ. Resistance training with vascular occlusion: metabolic adaptations in human muscle. Med Sci Sports Exerc. 2003 Jul;35(7):1203-8. doi: 10.1249/01.MSS.0000074458.71025.71.
PubMed 12840643Takarada Y, Tsuruta T, Ishii N. Cooperative effects of exercise and occlusive stimuli on muscular function in low-intensity resistance exercise with moderate vascular occlusion. Jpn J Physiol. 2004 Dec;54(6):585-92. doi: 10.2170/jjphysiol.54.585.
PubMed 15760491Loenneke JP, Kim D, Fahs CA, Thiebaud RS, Abe T, Larson RD, Bemben DA, Bemben MG. Effects of exercise with and without different degrees of blood flow restriction on torque and muscle activation. Muscle Nerve. 2015 May;51(5):713-21. doi: 10.1002/mus.24448.
PubMed 25187395Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PubMed 28259850Loenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
PubMed 21410544DePhillipo NN, Kennedy MI, Aman ZS, Bernhardson AS, O'Brien L, LaPrade RF. Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. Arthrosc Tech. 2018 Sep 24;7(10):e1037-e1043. doi: 10.1016/j.eats.2018.06.010. eCollection 2018 Oct.
PubMed 30377584Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.
PubMed 27749358Iversen E, Rostad V, Larmo A. Intermittent blood flow restriction does not reduce atrophy following anterior cruciate ligament reconstruction. J Sport Health Sci. 2016 Mar;5(1):115-118. doi: 10.1016/j.jshs.2014.12.005. Epub 2015 Apr 18.
PubMed 30356481
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04519801
- Acronym / sponsor ID
- C.2020.053
- Conditions
- ACL Injury
- Keywords
- BFR, ACLR, Quadriceps Tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- American Orthopaedic Society for Sports Medicine, Congressionally Directed Medical Research Programs
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 20 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.
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 16 weeks, and at 56 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 28 weeks, 40 weeks, and 56 weeks post-operative (secondary outcome measures).
Detailed description
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following ACLR standardized with respect to both surgical technique and graft selection. The investigator's central hypothesis is that the addition of BFR therapy has the potential to accelerate surgical recovery, expedite return-to-duty, and maximize medical readiness following ACLR. In the proposed trial validated isokinetic and isometric quadriceps strength testing will be used to quantify the effect of therapy on quadriceps strength, patient reported outcome measures will be used to assess for functional clinical improvement, while quadriceps musculature volume as measured on MRI will be used as an effort independent measure of quadriceps recovery. The rationale for using this modality is based upon the fact that the measurement of quadriceps CSA and muscle volume as surrogates for overall quadriceps function is well described, and a number of studies have convincingly demonstrated positive correlations between these parameters and quadriceps strength4, 17. However, in spite of these reports, the acceptance acknowledging MRI as a surrogate for quadriceps strength remains limited. Therefore, isokinetic and isometric quadriceps strength of both the operative and non-operative knee extensors (quadriceps) will be measured pre-operatively within 7-10 days approximately prior to ACLR and post-operatively at approximately 16 weeks, 28 weeks, 40 weeks, and 56 weeks. MRI of bilateral thighs will be performed immediately prior to ACLR to establish a baseline CSA in the operative and non-operative lower extremity. Then a repeat MRI will be performed following the conclusion of a standardized 12-week (approximately) post-operative rehabilitation regimen among patients randomized to either a standard rehabilitation regimen (REHAB) or a rehabilitation regimen with BFR (REHAB + BFR.) Finally, MRI will be repeated at 56 weeks post-operative to examine for latent changes in CSA once patients have been returned to unrestricted physical activities.
AIM 1: To determine if the addition of BFR therapy to a standard post-operative rehabilitation protocol increases functional strength and quadriceps muscle volume as measured with magnetic resonance imaging (MRI) after ACLR.
Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will increase quadriceps strength and muscle volume when compared to a standard post-operative rehabilitation regimen measured at approximately 16-weeks post-operative.
AIM 2: To determine if any observed increases in quadriceps strength and muscle volume are sustained beyond the cessation of BFR therapy at approximately 56 weeks post-operative.
Hypothesis: Observed increases in quadriceps strength and muscle volume will be sustained beyond the cessation of BFR therapy at 56 weeks post-operative.
AIM 3: To determine if CSA measurements obtained by MRI reliably predict knee extensor strength.
Hypothesis: CSA measurements obtained by MRI reliably predict knee extensor strength as measured by isokinetic and isometric testing.
AIM 4: To determine if the addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR results in significantly improved functional outcomes when compared to a standard post-operative rehabilitation regimen at 28, 40, and 56 weeks post-operative using patient reported outcomes (PRO).
Hypothesis: The addition of BFR therapy to a standard post-operative rehabilitation regimen following ACLR will result in significantly improved PRO when compared to a standard post-operative rehabilitation regimen at 28, 40, and 56-weeks post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| REHAB | Other | Other: Standard REHABStandard post-operative rehabilitation regimen (REHAB) (Control) |
| REHAB + BFR | Experimental | Other: Blood Flow Restriction (BFR) therapy, Other: Standard REHABStandard rehabilitation regimen with BFR therapy (REHAB + BFR) (Experimental) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Active duty member or Department of Defense Military Health System beneficiary
- 15 to 45 years of age
- Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates
Key exclusion criteria (5 listed)
- Patients undergoing a concomitant surgical procedure that would otherwise require a period of immobilization and/or restricted weight bearing (i.e. meniscal repair, meniscal allograft transplantation, osteochondral allograft transplantation, high tibial osteotomy) will be excluded.
- Undergoing combined multiligamentous knee injury reconstruction
- Unable to consistently participate in the prescribed post-operative rehabilitation regimen
- No patients with a history of recent lower extremity deep vein thrombosis, within the 12 months or on active treatment with anticoagulants, a history of ipsilateral lower extremity lymph node dissection or a history of endothelial dysfunction.
- Patients that are unable to obtain MRI secondary to either intolerance and/or implanted medical devices that preclude the safe completion of the MRI.
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 (BFR) therapyBFR therapy beginning after first MD follow up appointment after ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion. | Other | REHAB + BFR |
| Standard REHABStandard post-operative rehabilitation regimen (REHAB) beginning after first MD follow up appointment ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion | Other | REHAB, REHAB + BFR |
Primary outcome
Knee extensor strength
Time frame: [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 16 weeks post operatively] [Time Frame: 28 weeks post-operatively] [Time Frame: 40 weeks post-operatively] [Time Frame: 56 weeks post-operatively]
Knee extensor isokinetic and isometric strength measurements
7 secondary outcomes
Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS)
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - Lysholms Score
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS)
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) (Short version 6Q)
Time frame: [Time Frame: pre-operatively] [Time Frame: 7 months post-operatively] [Time Frame: 10 months post-operatively] [Time Frame: 13 months post-operatively]
Quadriceps volume
Time frame: [Timeframe: within 7-10 days of ACLR] [Time Frame: approximately 16 weeks post operative] [Time Frame: approximately 56 weeks post-operative]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 26920430Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
- Background: PubMed 26720104Goetschius J, Hart JM. Knee-Extension Torque Variability and Subjective Knee Function in Patients with a History of Anterior Cruciate Ligament Reconstruction. J Athl Train. 2016 Jan;51(1):22-7. doi: 10.4085/1062-6050-51.1.12. Epub 2015 Dec 31.
- Background: PubMed 26183172Zwolski C, Schmitt LC, Quatman-Yates C, Thomas S, Hewett TE, Paterno MV. The influence of quadriceps strength asymmetry on patient-reported function at time of return to sport after anterior cruciate ligament reconstruction. Am J Sports Med. 2015 Sep;43(9):2242-9. doi: 10.1177/0363546515591258. Epub 2015 Jul 16.
- Background: PubMed 25683732Thomas AC, Wojtys EM, Brandon C, Palmieri-Smith RM. Muscle atrophy contributes to quadriceps weakness after anterior cruciate ligament reconstruction. J Sci Med Sport. 2016 Jan;19(1):7-11. doi: 10.1016/j.jsams.2014.12.009. Epub 2015 Jan 13.
- Background: PubMed 25203517Kuenze C, Hertel J, Saliba S, Diduch DR, Weltman A, Hart JM. Clinical thresholds for quadriceps assessment after anterior cruciate ligament reconstruction. J Sport Rehabil. 2015 Feb;24(1):36-46. doi: 10.1123/jsr.2013-0110. Epub 2014 Sep 8.
- Background: PubMed 29949109Johnston PT, McClelland JA, Webster KE. Lower Limb Biomechanics During Single-Leg Landings Following Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Sep;48(9):2103-2126. doi: 10.1007/s40279-018-0942-0.
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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.
Andrew J Sheean, MD principal investigator
Brooke Army Medical Center
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 (BFR) therapy and Standard REHAB in people with ACL Injury, run by Brooke Army Medical Center 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 3 inclusion and 5 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 29 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee extensor strength (time frame: [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 16 weeks post operatively] [Time Frame: 28 weeks post-operatively] [Time Frame: 40 weeks post-operatively] [Time Frame: 56 weeks post-operatively]). 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 NCT04519801, which also lists 26 linked publications.
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 29 Jun 2026.