BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft

NCT04519801 | Active Not Recruiting

• 1 other identifier: C.2020.053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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 12 weeks, and at 52 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 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).

Conditions

ACL Injury

Keywords

BFR; ACLR; Quadriceps Tendon

Outcome Measures

Primary Outcomes (2)

• Quadriceps CSA MRI

  Quadriceps CSA as measured on MRI

  [Timeframe: within 7-10 days of ACLR] [Time Frame: approximately 12-14 weeks post operative] [Time Frame: approximately 52-54 weeks post-operative]

• Knee extensor strength

  Knee extensor isokinetic and isometric strength measurements

  [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 12 weeks post operatively] [Time Frame: 24 weeks post-operatively] [Time Frame: 36 weeks post-operatively] [Time Frame: 52 weeks post-operatively]

Secondary Outcomes (6)

• Patient Reported Outcome - Pain on 10 cm Visual Analog Scale (VAS)

  [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]

• Patient Reported Outcome - Lyscholms Score

  [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]

• Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)

  [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]

• Patient Reported Outcome - Knee Osteoarthritis Outcome Score (KOOS)

  [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]

• Connor-Davidson Resilience Scale (CD-RISC)

  [Time Frame: pre-operatively] [Time Frame: 6 months post-operatively] [Time Frame: 9 months post-operatively] [Time Frame: 12 months post-operatively]

Study Arms (2)

REHAB

OTHER

Standard post-operative rehabilitation regimen (REHAB) (Control)

Other: Standard REHAB

REHAB + BFR

EXPERIMENTAL

Standard rehabilitation regimen with BFR therapy (REHAB + BFR) (Experimental)

Other: Blood Flow Restriction (BFR) therapy; Other: Standard REHAB

Interventions

Blood Flow Restriction (BFR) therapy OTHER

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.

REHAB + BFR

Standard REHAB OTHER

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

REHAB; REHAB + BFR

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Active duty member or Department of Defense Military Health System beneficiary
• to 45 years of age
• Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• American Orthopaedic Society for Sports Medicine: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Brooke Army Medical Center- Clinical Research Center

San Antonio, Texas, 78234, United States

Location

Related Publications (26)

• 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.

  PMID: 26920430 BACKGROUND

• Goetschius 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.

  PMID: 26720104 BACKGROUND

• Zwolski 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.

  PMID: 26183172 BACKGROUND

• Thomas 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.

  PMID: 25683732 BACKGROUND

• Kuenze 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.

  PMID: 25203517 BACKGROUND

• Johnston 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.

  PMID: 29949109 BACKGROUND

• Garber 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.

  PMID: 21694556 BACKGROUND

• Burgomaster 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.

  PMID: 12840643 BACKGROUND

• Takarada 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.

  PMID: 15760491 BACKGROUND

• Loenneke 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.

  PMID: 25187395 BACKGROUND

• Hughes 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.

  PMID: 28259850 BACKGROUND

• Loenneke 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.

  PMID: 21410544 BACKGROUND

• DePhillipo 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.

  PMID: 30377584 BACKGROUND

• Tennent 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.

  PMID: 27749358 BACKGROUND

• Iversen 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.

  PMID: 30356481 BACKGROUND

• Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.

  PMID: 11128848 BACKGROUND

• Kuenze CM, Blemker SS, Hart JM. Quadriceps function relates to muscle size following ACL reconstruction. J Orthop Res. 2016 Sep;34(9):1656-62. doi: 10.1002/jor.23166. Epub 2016 Jan 27.

  PMID: 26763833 BACKGROUND

• Sheean AJ, Musahl V, Slone HS, Xerogeanes JW, Milinkovic D, Fink C, Hoser C; International Quadriceps Tendon Interest Group. Quadriceps tendon autograft for arthroscopic knee ligament reconstruction: use it now, use it often. Br J Sports Med. 2018 Jun;52(11):698-701. doi: 10.1136/bjsports-2017-098769. Epub 2018 Apr 28.

  PMID: 29705749 BACKGROUND

• Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.

  PMID: 28205075 BACKGROUND

• Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.

  PMID: 28186223 BACKGROUND

• Briggs KK, Steadman JR, Hay CJ, Hines SL. Lysholm score and Tegner activity level in individuals with normal knees. Am J Sports Med. 2009 May;37(5):898-901. doi: 10.1177/0363546508330149. Epub 2009 Mar 23.

  PMID: 19307332 BACKGROUND

• Ra HJ, Kim HS, Choi JY, Ha JK, Kim JY, Kim JG. Comparison of the ceiling effect in the Lysholm score and the IKDC subjective score for assessing functional outcome after ACL reconstruction. Knee. 2014 Oct;21(5):906-10. doi: 10.1016/j.knee.2014.06.004. Epub 2014 Jun 21.

  PMID: 24998912 BACKGROUND

• Grevnerts HT, Terwee CB, Kvist J. The measurement properties of the IKDC-subjective knee form. Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3698-706. doi: 10.1007/s00167-014-3283-z. Epub 2014 Sep 6.

  PMID: 25193574 BACKGROUND

• Gerber JP, Marcus RL, Dibble LE, Greis PE, Burks RT, LaStayo PC. Effects of early progressive eccentric exercise on muscle structure after anterior cruciate ligament reconstruction. J Bone Joint Surg Am. 2007 Mar;89(3):559-70. doi: 10.2106/JBJS.F.00385.

  PMID: 17332105 BACKGROUND

• Agarwalla A, Puzzitiello RN, Liu JN, Cvetanovich GL, Gowd AK, Verma NN, Cole BJ, Forsythe B. Timeline for Maximal Subjective Outcome Improvement After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Aug;47(10):2501-2509. doi: 10.1177/0363546518803365. Epub 2018 Nov 12.

  PMID: 30419175 BACKGROUND

• Prue J, Roman DP, Giampetruzzi NG, Fredericks A, Lolic A, Crepeau A, Pace JL, Weaver AP. Side Effects and Patient Tolerance with the Use of Blood Flow Restriction Training after ACL Reconstruction in Adolescents: A Pilot Study. Int J Sports Phys Ther. 2022 Apr 2;17(3):347-354. doi: 10.26603/001c.32479. eCollection 2022.

  PMID: 35391873 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Andrew J Sheean, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The operating surgeon will remain blinded to the post-operative rehabilitation regimen to which subjects are randomized to post-operative rehabilitation regimen (REHAB vs. REHAB + BFR.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Principal Investigator, Staff Orthopaedic Surgeon

Model Details: Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 20, 2020
• Study Start: September 9, 2022
• Primary Completion: February 28, 2026
• Study Completion: April 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)