Healing potential of the anterior cruciate ligament in terms of fiber continuity after a complete rupture: A systematic review.
Alexios Pitsillides, Dimitrios Stasinopoulos, Konstantinos Giannakou
https://pubmed.ncbi.nlm.nih.gov/34776148Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
All Genders
ID06727344
Comparison of Conservative Treatment With Blood Flow Restriction With Standard Management in Total ACL Rupture Randomized Clinical Trial
Led by European University Cyprus · Updated on 2025-04-03
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of exercise combined with blood flow restriction (BFR) in patients who have a complete anterior cruciate ligament (ACL) rupture. This randomized clinical trial aims to determine if adding BFR provides extra benefits to the conservative treatment of ACL injuries and whether using a knee brace promotes spontaneous healing. The study compares two groups: one receiving bracing combined with BFR exercise and the other receiving bracing with sham BFR, to understand the added value of BFR in managing ACL rupture. Participants in the intervention group will wear a knee brace for 6 weeks, with adjustments made in phases to gradually increase knee movement and weight bearing. They will follow a detailed exercise program that progresses through phases, starting with isometric contractions and advancing to resistance exercises and gait training, all performed under BFR except for some later exercises. The control group follows the same splinting and exercise plan but with sham BFR instead of real blood flow restriction. Both groups will continue home-based exercises monitored through an electronic platform that ensures proper execution and compliance. Throughout the study, participants will undergo initial assessments including MRI, strength tests, swelling measurement, knee laxity evaluation, pain scales, and functional scores. Strength, swelling, and pain will be reassessed during weeks 2 and 4, with a final evaluation at the end of the 12-week intervention including all initial measures. Compliance with the home exercise program will be tracked digitally. The main outcome measured is strength, with secondary outcomes including MRI changes, knee stability, balance, swelling, pain, and patient-reported outcomes. The trial follows a double-blind, randomized design to provide reliable data on the benefits of BFR in ACL rupture treatment.
CONDITIONS
Brief Title
Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"
Who Can Participate
Age: 18Years - 40Years
All Genders
Eligibility Criteria
You may qualify if you...
- MRI-confirmed complete rupture of ACL
- Ability to communicate and read fluently in Greek
- Willingness to keep leg immobilised for the required period based on the study protocol
- Age between 18 and 40 years
You will not qualify if you...
- 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 preventing use of blood flow restriction, such as open wounds, serious skin problems, or allergies to cuff material
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants follow a conservative treatment protocol involving use of a knee brace and a structured exercise program. Exercises are performed with either blood flow restriction or sham restriction. The brace limits knee motion in phases over the first 6 weeks, followed by unrestricted walking. Exercises progress in difficulty and range of motion over 12 weeks.
Visits at enrollment, week 2, week 4, and end of intervention (week 12) for assessments
Trial Site Locations
Total: 2 locations
1
European University Cyprus
Nicosia, Cyprus, 2404
Actively Recruiting
2
European University Cyprus
Nicosia, Cyprus, 2404
Actively Recruiting
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Research Team
A
Alexis N Pitsillides, PhD candidate
C
Christos Karagiannis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Healing of acute anterior cruciate ligament rupture on MRI and outcomes following non-surgical management with the Cross Bracing Protocol.
Stephanie R Filbay, Matthew Dowsett, Mohammad Chaker Jomaa...
https://pubmed.ncbi.nlm.nih.gov/37316199Conservative treatment using blood flow restriction and brace in individuals with complete anterior cruciate ligament rupture: protocol for a randomised clinical trial.
Alexios Pitsillides, Antonis Constantinou, Christos Karagiannis...
https://pubmed.ncbi.nlm.nih.gov/41327334