ACL Bone Health and Loading Study

NCT04682392 | Unknown FDA Device

• 1 other identifier: PAR20-0625-ACL-bonehealth
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health. Hypothesis: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group.

Conditions

ACL Tear

Keywords

Blood Flow Restriction (BFR)

Outcome Measures

Primary Outcomes (1)

• Leg Weight distribution landing on force plates

  Athlete landing on force plates from and 18 inch height to compare loading / weight symmetry

  week 28 post surgery

Secondary Outcomes (1)

• Bone mineral density

  Week 28 post surgery

Study Arms (2)

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group

ACTIVE COMPARATOR

This group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab.

Device: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group; Other: Standard ACL rehab

Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group

ACTIVE COMPARATOR

Standard post operative ACL rehab without Blood flow restriction

Other: Standard ACL rehab

Interventions

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group DEVICE

A Delphi Personal Tourniquet system for blood flow restriction (BFR) therapy will be applied to each treatment session for this group. They will do 3-5 exercises with the BFR system on the surgical or both lower extremities for bilateral or unilateral movements.

Also known as: A Dephi Personal Tourniquet System will be utilized for the experimental group.

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group

Standard ACL rehab OTHER

Standard accelerated ACL protocol

Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group; Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Athletes undergoing ACL reconstruction with or without meniscal pathology
• MRI confirming ACL tear
• Athletes ages 16-22

You may not qualify if:

• Any Cognitively impaired athletes
• Athletes not in age range of 16-22
• Athletes who have additional ligament repair or chondral repair.
• Athletes with any weight bearing restrictions greater than 4 weeks.
• Athletes with re-tears or history of contralateral ACL tears
• Athletes with any systemic neuromuscular or balance disorders will not be allowed
• Athletes who do not or are unable to provide consent or assent (with Parental consent).
• Pregnant women will be excluded.
• Athlete who has previously used Blood Flow Restriction
• Athletes who are unable or unwilling to complete all rehabilitation with Parkview Athletic Rehab at SportONE Parkview Fieldhouse

Sponsors & Collaborators

• Candice Dunkin, MS, LAT, ATC: lead
• Parkview Health: collaborator

Study Sites (1)

Parkview Athletic Rehab

Fort Wayne, Indiana, 46805, United States

RECRUITING

Related Publications (17)

• Nyland J, Fisher B, Brand E, Krupp R, Caborn DN. Osseous deficits after anterior cruciate ligament injury and reconstruction: a systematic literature review with suggestions to improve osseous homeostasis. Arthroscopy. 2010 Sep;26(9):1248-57. doi: 10.1016/j.arthro.2010.03.017.

  PMID: 20810081 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

• Lepley AS, Grooms DR, Burland JP, Davi SM, Kinsella-Shaw JM, Lepley LK. Quadriceps muscle function following anterior cruciate ligament reconstruction: systemic differences in neural and morphological characteristics. Exp Brain Res. 2019 May;237(5):1267-1278. doi: 10.1007/s00221-019-05499-x. Epub 2019 Mar 9.

  PMID: 30852644 BACKGROUND

• Kuenze CM, Foot N, Saliba SA, Hart JM. Drop-Landing Performance and Knee-Extension Strength After Anterior Cruciate Ligament Reconstruction. J Athl Train. 2015 Jun;50(6):596-602. doi: 10.4085/1062-6050-50.2.11. Epub 2015 May 15.

  PMID: 25978101 BACKGROUND

• 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: 10.1177/2325967120906822. eCollection 2020 Mar.

  PMID: 32232065 BACKGROUND

• Centner C, Ritzmann R, Schur S, Gollhofer A, Konig D. Blood flow restriction increases myoelectric activity and metabolic accumulation during whole-body vibration. Eur J Appl Physiol. 2019 Jun;119(6):1439-1449. doi: 10.1007/s00421-019-04134-5. Epub 2019 Apr 4.

  PMID: 30949807 BACKGROUND

• Lauver JD, Cayot TE, Rotarius T, Scheuermann BW. The effect of eccentric exercise with blood flow restriction on neuromuscular activation, microvascular oxygenation, and the repeated bout effect. Eur J Appl Physiol. 2017 May;117(5):1005-1015. doi: 10.1007/s00421-017-3589-x. Epub 2017 Mar 21.

  PMID: 28324168 BACKGROUND

• Lauver JD, Cayot TE, Rotarius TR, Scheuermann BW. Acute Neuromuscular and Microvascular Responses to Concentric and Eccentric Exercises With Blood Flow Restriction. J Strength Cond Res. 2020 Oct;34(10):2725-2733. doi: 10.1519/JSC.0000000000003372.

  PMID: 31524780 BACKGROUND

• 9. Lambert B, Hedt CA, Jack RA, et al. Blood Flow Restriction Therapy Preserves Whole Limb Bone and Muscle Following ACL Reconstruction. Orthop J Sport Med. 2019;7(3_suppl2):2325967119S0019. doi:10.1177/2325967119S00196

  BACKGROUND

• 10. Brandner CR, May AK, Clarkson MJ, Warmington SA. Reported side-effects and safety considerations for the use of blood flow restriction during exercise in practice and research. Tech Orthop. 2018;33(2):114-121. doi:10.1097/BTO.0000000000000259

  BACKGROUND

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 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

• Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018.

  PMID: 30246795 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

• Curran MT, Bedi A, Mendias CL, Wojtys EM, Kujawa MV, Palmieri-Smith RM. Blood Flow Restriction Training Applied With High-Intensity Exercise Does Not Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(4):825-837. doi: 10.1177/0363546520904008.

  PMID: 32167837 BACKGROUND

• Baim S, Wilson CR, Lewiecki EM, Luckey MM, Downs RW Jr, Lentle BC. Precision assessment and radiation safety for dual-energy X-ray absorptiometry: position paper of the International Society for Clinical Densitometry. J Clin Densitom. 2005 Winter;8(4):371-8. doi: 10.1385/jcd:8:4:371.

  PMID: 16311420 BACKGROUND

• Blake GM, Naeem M, Boutros M. Comparison of effective dose to children and adults from dual X-ray absorptiometry examinations. Bone. 2006 Jun;38(6):935-42. doi: 10.1016/j.bone.2005.11.007. Epub 2005 Dec 22.

  PMID: 16376161 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Candice Dunkin, MAT

  Parkview Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice Dunkin, MAT

CONTACT

260-385-1575; candice.dunkin@parkview.com

Thomas M Ruediger, DPT

CONTACT

8106181897; Tmruediger@manchester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Sports Medicine Parkview Sports Medicine

Model Details: 2 groups with Randomized group assignments

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 23, 2020
• Study Start: February 17, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)