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NCT Number: NCT05972876

Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuyderland Medical Center

Sittard, Limburg, 6162 BG, Netherlands

Location status: Recruiting

Location contact

Jasper Most

CONTACT

[email protected]

+31(0)625159747

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood flow restriction training

Behavioral

BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure

Resistance training

Behavioral

Resistance training will be performed without any blood flow restriction

Primary outcomes

  1. Graft Maturity

    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)

Secondary outcomes

  1. Range of motion

    Time frame: 3 and 9 months after surgery

    Range of motion will be evaluated with the use of a goniometer.

  2. Knee stability

    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

  3. Anterior knee pain

    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

  4. Knee pain and function

    Time frame: 3 and 9 months after surgery

    Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)

  5. Knee function

    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

  6. patient confidence

    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

  7. hamstring strength

    Time frame: 3 and 9 months after surgery

    Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO

  8. isokinetic quadriceps strength

    Time frame: 3 and 9 months after surgery

    Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO

  9. Return to pre-injury level of sport

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jasper Most, PhD

CONTACT

[email protected]

0031625159747

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Official study title

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

Acronym: TimeToMature

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2023
Registry last updated
Feb 4, 2025

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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