Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05972876

Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction — TimeToMature  

Anterior Cruciate Ligament Reconstruction Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction
Clinical Trial Details
NCT number NCT05972876
Study type Interventional
Source Zuyderland Medisch Centrum
Contact Jasper Most, PhD
Phone 0031625159747
Email j.most@zuyderland.nl
Status Not yet recruiting
Phase N/A
Start date October 2023
Completion date September 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT06280456 - Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction N/A
Active, not recruiting NCT02772770 - Pediatric ACL: Understanding Treatment Options
Terminated NCT00300300 - Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques Phase 4
Completed NCT00775892 - SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair Phase 1/Phase 2
Completed NCT04504344 - Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction Phase 1
Recruiting NCT06327555 - Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction N/A
Recruiting NCT05968729 - Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol N/A
Withdrawn NCT03688477 - Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation N/A
Completed NCT02945553 - Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery Phase 1/Phase 2
Recruiting NCT01279759 - Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction N/A
Completed NCT00245271 - Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Phase 3
Recruiting NCT06131047 - High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction N/A
Recruiting NCT06206200 - The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Not yet recruiting NCT06318039 - Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction N/A
Recruiting NCT03336060 - Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function N/A
Completed NCT03304561 - The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction N/A
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A
Completed NCT02604550 - Anterior Cruciate Ligament Pain Study Phase 4
Completed NCT02257164 - Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial Phase 4