NCT05972876

Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anterior Cruciate Ligament Reconstruction
• Bone-Patellar Tendon-Bone Grafting

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-08-02
• Last updated: 2025-02-04

Locations

1 site across 1 country: Netherlands