Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study

Conditions
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Bone-Patellar Tendon-Bone Grafting, Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Behavioral: Blood flow restriction training
* Behavioral: Resistance training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood flow restriction training (BFRT)<br>Patients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum | Behavioral: Blood flow restriction training<br>* BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure<br>|
| Active Comparator: Resistance training (RT)<br>Patients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum | Behavioral: Resistance training<br>* Resistance training will be performed without any blood flow restriction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Maturity | Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI) | 3 and 9 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Range of motion will be evaluated with the use of a goniometer. | 3 and 9 months after surgery | 
| Knee stability | With patients lying supine in 30° of flexion anterior tibial translation in mm will be measured with the use of a Rolimeter | 3 and 9 months after surgery | 
| Anterior knee pain | anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain | 3 and 9 months after surgery | 
| Knee pain and function | Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome) | 3 and 9 months after surgery | 
| Knee function | knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome | 3 and 9 months after surgery | 
| patient confidence | using the Anterior Cruciate Ligament Return To Sport after Injury scale, 0 to 100, 100 being the best outcome | 3 and 9 months after surgery | 
| hamstring strength | Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO | 3 and 9 months after surgery | 
| isokinetic quadriceps strength | Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO | 3 and 9 months after surgery | 
| Return to pre-injury level of sport | Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report | 9 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Flow Restriction Therapy