Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZuyderland Medisch Centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.
Disqualifiers
venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.
Trial design
Design model
Parallel
Treatments tested in this trial
Blood flow restriction training
BehavioralBFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
Resistance training
BehavioralResistance training will be performed without any blood flow restriction
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Blood flow restriction training (BFRT)Experimental treatment 1 intervention
Group B: Resistance training (RT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Graft Maturity
Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)
Time frame
3 and 9 months after surgerySecondary outcomes
1
Range of motion
Range of motion will be evaluated with the use of a goniometer.
Time frame
3 and 9 months after surgery2
Knee stability
With patients lying supine in 30° of flexion anterior tibial translation in mm will be measured with the use of a Rolimeter
Time frame
3 and 9 months after surgery3
Anterior knee pain
anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain
Time frame
3 and 9 months after surgery4
Knee pain and function
Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)
Time frame
3 and 9 months after surgerySponsors and contacts
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Source ClinicalTrials.gov