Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05972876

Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

Led by Zuyderland Medisch Centrum · Updated on 2025-02-04

46

Participants Needed

1

Research Sites

176 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 64 years
  • Undergoing primary bone-patellar tendon-bone (BPTB) ACL reconstruction at Zuyderland Medical Center
  • Rehabilitation at Knie-Heup centrum Plus
Not Eligible

You will not qualify if you...

  • History of venous thromboembolism
  • Sickle cell anemia
  • Severe hypertension
  • Contraindication for accelerated rehabilitation
  • Contraindication for MRI scan
  • Not willing or able to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zuyderland Medical Center

Sittard, Limburg, Netherlands, 6162 BG

Actively Recruiting

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Research Team

J

Jasper Most, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction | DecenTrialz