Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood flow restriction training, Resistance training.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Reconstruction, Bone-Patellar Tendon-Bone Grafting. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
Overview
Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment. Objectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed. Study design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing/able to participate. Intervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery. Comparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery. Main study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.
Interventions
- Behavioral Blood flow restriction training
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure - Behavioral Resistance training
Resistance training will be performed without any blood flow restriction
Primary outcome measures
- Graft Maturity [Time frame: 3 and 9 months after surgery]
Secondary outcome measures (9)
- Range of motion [Time frame: 3 and 9 months after surgery]
- Knee stability [Time frame: 3 and 9 months after surgery]
- Anterior knee pain [Time frame: 3 and 9 months after surgery]
- Knee pain and function [Time frame: 3 and 9 months after surgery]
- Knee function [Time frame: 3 and 9 months after surgery]
- patient confidence [Time frame: 3 and 9 months after surgery]
- hamstring strength [Time frame: 3 and 9 months after surgery]
- isokinetic quadriceps strength [Time frame: 3 and 9 months after surgery]
- Return to pre-injury level of sport [Time frame: 9 months after surgery]
Eligibility criteria
Inclusion criteria
- Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.
Exclusion criteria
- venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Zuyderland Medical Center — Sittard
Identifiers
NCT: NCT05972876 · NL83376.096.22