Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Muscle Weakness Clinical Trial

— ACL BFR  

Official title:

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735236
• Other study ID #: 22-1052
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: November 8, 2025

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Lauren Heylmun, BS
• Phone: 720-516-9823
• Email: lauren.heylmun[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy.

Description:

The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy. The current standard of care and post-operative pain levels can limit patients from applying load necessary to increase muscle size and strength development due to partial weight baring after surgery. We hypothesize that immediate and consistent use of BFR augmenting our current standard post operative knee arthroscopy rehabilitation protocol will result in greater improvement in strength and quicker achievement of phase-based rehabilitation goals. We hypothesize that these objective improvements in strength will correlate with clinically meaningful improvement in Tegner activity scale, International Knee Documentation Committee (IKDC), return to sport, Lower Extremity Functional Scale (LEFS), pain and resiliency (patient reported outcome, PRO) scores indicative of greater functional recovery compared to our standard rehabilitation protocol alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: November 8, 2025
• Est. primary completion date: November 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.

Exclusion Criteria:

• Bilateral knee surgeries to be performed within 12 weeks of each other, meniscus repairs, chondral lesion repair/transplants, ACL revisions that utilize contralateral autografts, MCL repairs, and the following BFR contraindications: deep vein thrombosis (DVT), pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or taking blood thinners, pregnant or up to 6 months postpartum, untreated hypertension, untreated hypotension, rhabdomyolysis or recent traumatic injury, does not understand English, and the following BFR contraindications:

1. Contraindications for BFR

• Deep Vein Thrombosis (DVT)

• Pulmonary Embolism

• Hemorrhagic/Thrombolytic Stroke

• Clotting Disorders

• Hemophilia or taking blood thinners

• Pregnant or up to 6 months post-partum

• Untreated Hypertension

• Untreated Hypotension

• Rhabdomyolysis or recent traumatic injury

2. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician.

3. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study.

4. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.

Related Conditions & MeSH terms

• Muscle Atrophy
• Muscle Weakness
• Muscular Atrophy

Intervention

Device:
• BFR Cuff
The BFR cuff will be applied to the proximal thigh of the surgical leg while the patient completes specified physical therapy exercises.80% occlusion pressure will be determined by PT's in clinic through the use of a Delphi unit. Subjects will then be able to use the Saga Fitness app to adjust this pressure if it differs from the automatic calibrated pressure.

Locations

Country	Name	City	State
United States	UCHealth Steadman Hawkins Clinic	Centennial	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (17)

Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14. — View Citation

Bronner S, Chodock E, Urbano IER, Smith T. Psychometric Properties of the Dance Functional Outcome Survey (DFOS): Reliability, Validity, and Responsiveness. J Orthop Sports Phys Ther. 2019 Feb;49(2):64-79. doi: 10.2519/jospt.2019.8247. Epub 2018 Jul 27. — View Citation

Chahal J, Van Thiel GS, Mather RC 3rd, Lee S, Song SH, Davis AM, Salata M, Nho SJ. The Patient Acceptable Symptomatic State for the Modified Harris Hip Score and Hip Outcome Score Among Patients Undergoing Surgical Treatment for Femoroacetabular Impingeme — View Citation

Charles D, White R, Reyes C, Palmer D. A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION. Int J Sports Phys Ther. 2020 Dec;15(6):882-891. doi: 10.26603/ijspt2020088 — View Citation

Enseki K, Harris-Hayes M, White DM, Cibulka MT, Woehrle J, Fagerson TL, Clohisy JC; Orthopaedic Section of the American Physical Therapy Association. Nonarthritic hip joint pain. J Orthop Sports Phys Ther. 2014 Jun;44(6):A1-32. doi: 10.2519/jospt.2014.030 — View Citation

Grzybowski JS, Malloy P, Stegemann C, Bush-Joseph C, Harris JD, Nho SJ. Rehabilitation Following Hip Arthroscopy - A Systematic Review. Front Surg. 2015 May 26;2:21. doi: 10.3389/fsurg.2015.00021. eCollection 2015. — View Citation

Hung M, Saltzman CL, Kendall R, Bounsanga J, Voss MW, Lawrence B, Spiker R, Brodke D. What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions? Clin Orthop Relat Res. 2018 Oct;476(10):2027-2036. doi: 10.1097/CORR.00000 — View Citation

Ingram JG, Fields SK, Yard EE, Comstock RD. Epidemiology of knee injuries among boys and girls in US high school athletics. Am J Sports Med. 2008 Jun;36(6):1116-22. doi: 10.1177/0363546508314400. Epub 2008 Mar 28. — View Citation

Joseph AM, Collins CL, Henke NM, Yard EE, Fields SK, Comstock RD. A multisport epidemiologic comparison of anterior cruciate ligament injuries in high school athletics. J Athl Train. 2013 Nov-Dec;48(6):810-7. doi: 10.4085/1062-6050-48.6.03. Epub 2013 Oct — View Citation

Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177 — View Citation

Luebbers PE, Witte EV, Oshel JQ, Butler MS. Effects of Practical Blood Flow Restriction Training on Adolescent Lower-Body Strength. J Strength Cond Res. 2019 Oct;33(10):2674-2683. doi: 10.1519/JSC.0000000000002302. — View Citation

Powell JW, Barber-Foss KD. Injury patterns in selected high school sports: a review of the 1995-1997 seasons. J Athl Train. 1999 Jul;34(3):277-84. — View Citation

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. 202 — View Citation

Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28. — View Citation

Tabata S, Suzuki Y, Azuma K, Matsumoto H. Rhabdomyolysis After Performing Blood Flow Restriction Training: A Case Report. J Strength Cond Res. 2016 Jul;30(7):2064-8. doi: 10.1519/JSC.0000000000001295. — View Citation

Weatherholt AM, Vanwye WR, Lohmann J, Owens JG. The Effect of Cuff Width for Determining Limb Occlusion Pressure: A Comparison of Blood Flow Restriction Devices. Int J Exerc Sci. 2019 Jan 1;12(3):136-143. eCollection 2019. — View Citation

Yasuda T, Fukumura K, Fukuda T, Uchida Y, Iida H, Meguro M, Sato Y, Yamasoba T, Nakajima T. Muscle size and arterial stiffness after blood flow-restricted low-intensity resistance training in older adults. Scand J Med Sci Sports. 2014 Oct;24(5):799-806. d — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee extensor strength	Strength of knee extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative lim	6 months
Secondary	hamstrings musculature strength	Strength of knee flexors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb.	6 months
Secondary	single leg squat test	Performance on a Repeated Single Leg Squat test to 45 deg knee flexion over the course of 90 seconds reported as a measure of LSI	6 months
Secondary	Tegner Activity Scale	Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)	6 months
Secondary	LEFS	Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = ? 123	2 years
Secondary	Pain NPRS	Range 1 (low pain) -10 (high pain); MDC = ? 34	2 Years
Secondary	PROMIS Pain	Range 0 (low pain) -100 (highpain); MDC = ? 85	2 Years
Secondary	PROMIS Physical Function	Range 0 (low function) -100 (high function); MDC = ? 85	2 Years
Secondary	Brief Resiliency Score (BRS)	Range 1(low resilience) -5 (high resilience); MDC = ? low (1-2.99) to normal (3-4.3) to high (4.31-5)	2 Years
Secondary	ACL-RSI	Range 1 (low function) -100 (high function); MDC = ?15.1 for short form version	2 Years
Secondary	IKDC	Range 1 (low function) -100 (high function); MDC = ?8.8 low to ?15.6 high	2 Years