NCT05972876 Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
| NCT ID | NCT05972876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zuyderland Medisch Centrum |
| Condition | Anterior Cruciate Ligament Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2024-04-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Frequently Asked Questions
Who can join the NCT05972876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Anterior Cruciate Ligament Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05972876 currently recruiting?
Yes, NCT05972876 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zuyderland Medisch Centrum to inquire about joining.
Where is the NCT05972876 trial being conducted?
This trial is being conducted at Sittard, Netherlands.
Who is sponsoring the NCT05972876 clinical trial?
NCT05972876 is sponsored by Zuyderland Medisch Centrum. The trial plans to enroll 46 participants.