Zuyderland Medical Center
Sittard, Limburg, 6162 BG, Netherlands
Location status: Recruiting
NCT Number: NCT05972876
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Sittard, Limburg, 6162 BG, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
Resistance training will be performed without any blood flow restriction
Time frame: 3 and 9 months after surgery
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 surgery
Range of motion will be evaluated with the use of a goniometer.
Time frame: 3 and 9 months after surgery
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 surgery
anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain
Time frame: 3 and 9 months after surgery
Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)
Time frame: 3 and 9 months after surgery
knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome
Time frame: 3 and 9 months after surgery
using the Anterior Cruciate Ligament Return To Sport after Injury scale, 0 to 100, 100 being the best outcome
Time frame: 3 and 9 months after surgery
Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO
Time frame: 3 and 9 months after surgery
Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO
Time frame: 9 months after surgery
Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report
Contact information is provided by the study sponsor or research team.
Zuyderland Medisch Centrum
Other
MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
Acronym: TimeToMature
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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