Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"

NCT06727344 | Recruiting

• 1 other identifier: ΕΕΒΚ/ΕΠ/2024/70
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture. The main questions it aims to answer are:

1. 1.Does blood flow restriction adds any additional benefits to conservative treatment of the ACL?
2. 2.Does bracing promotes spontaneous healing to the ACL
3. 3.Use a knee brace for 6 weeks with adjustments according to protocol
4. 4.Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group)
5. 5.Follow a home based exercise program.

Conditions

ACL; ACL - Anterior Cruciate Ligament Rupture

Keywords

BFR; Blood Flow Restriction; Brace; ACL rupture; ACL

Outcome Measures

Primary Outcomes (1)

• Strength

  Quadriceps strength using a hand held dynamometer

  Enrolment, week 2 and 4, end of intervention (12 weeks)

Secondary Outcomes (7)

• MRI

  Enrolment and end of intervention at 12 weeks

• Knee laxity

  enrolment and end of intervention at 12 weeks

• Balance

  enrolment and end of intervention at 12 weeks

• Swelling

  enrolment and end of intervention at 12 weeks

• Visual analog scale (VAS)

  enrolment, week 2 and 4 and end of intervention at 12 weeks

Study Arms (2)

Brace and BFR exercise

EXPERIMENTAL

Other: Blood Flow Restriction; Other: Brace

Brace and BFR sham

SHAM COMPARATOR

Other: Brace

Interventions

Blood Flow Restriction OTHER

Exercise with restriction of blood flow supply

Brace and BFR exercise

Brace OTHER

Knee brace to restrict range of motion

Brace and BFR exercise; Brace and BFR sham

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• MRI-confirmed complete rupture of ACL. Ability to communicate and read fluently in Greek and be willing to keep their leg immobilised for the required period based on the study protocol.

You may not qualify if:

• Heart disease, overweight, diabetes, pregnancy, thrombophilia, atrial fibrillation, heart failure, cancer, use of drugs that may increase blood clotting, use of hormones or contraceptives, any reason for not using BFR e.g., an open wound or serious skin problems and/or allergies to the cuff material.

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (2)

European University Cyprus

Nicosia, 2404, Cyprus

RECRUITING

European University Cyprus

Nicosia, 2404, Cyprus

RECRUITING

Related Publications (3)

• Pitsillides A, Stasinopoulos D, Giannakou K. Healing potential of the anterior cruciate ligament in terms of fiber continuity after a complete rupture: A systematic review. J Bodyw Mov Ther. 2021 Oct;28:246-254. doi: 10.1016/j.jbmt.2021.06.003. Epub 2021 Jun 12.

  PMID: 34776148 BACKGROUND

• Filbay SR, Dowsett M, Chaker Jomaa M, Rooney J, Sabharwal R, Lucas P, Van Den Heever A, Kazaglis J, Merlino J, Moran M, Allwright M, Kuah DEK, Durie R, Roger G, Cross M, Cross T. Healing of acute anterior cruciate ligament rupture on MRI and outcomes following non-surgical management with the Cross Bracing Protocol. Br J Sports Med. 2023 Dec;57(23):1490-1497. doi: 10.1136/bjsports-2023-106931. Epub 2023 Jun 14.

  PMID: 37316199 BACKGROUND

• Pitsillides A, Constantinou A, Karagiannis C, Giannakou K. Conservative treatment using blood flow restriction and brace in individuals with complete anterior cruciate ligament rupture: protocol for a randomised clinical trial. J Orthop Surg Res. 2025 Dec 1;21(1):10. doi: 10.1186/s13018-025-06285-y.

  PMID: 41327334 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy; Braces

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Alexis N Pitsillides, PhD candidate

CONTACT

0035799418065; alexpitsillides@gmail.com

Christos Karagiannis, PhD

CONTACT

0035799912547; C.Karayiannis@euc.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexios Pitsillides BSc, MSc, PhD (cand)

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 10, 2024
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)