Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction (TimeToMature)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction; Bone-Patellar Tendon-Bone Grafting
• Intervention / Treatment: Behavioral: Blood flow restriction training; Behavioral: Resistance training

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasper Most, PhD; Phone Number: 0031625159747; Email: j.most@zuyderland.nl

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162 BG
      • Recruiting
      • Zuyderland Medical Center
      • Contact: Jasper Most; Phone Number: +31(0)625159747; Email: j.most@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction training (BFRT); Patients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum	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
Active Comparator: Resistance training (RT); Patients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum	Behavioral: Resistance training; Resistance training will be performed without any blood flow restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Maturity	Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)	3 and 9 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion will be evaluated with the use of a goniometer.	3 and 9 months after surgery
Knee stability	With patients lying supine in 30° of flexion anterior tibial translation in mm will be measured with the use of a Rolimeter	3 and 9 months after surgery
Anterior knee pain	anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain	3 and 9 months after surgery
Knee pain and function	Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)	3 and 9 months after surgery
Knee function	knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome	3 and 9 months after surgery
patient confidence	using the Anterior Cruciate Ligament Return To Sport after Injury scale, 0 to 100, 100 being the best outcome	3 and 9 months after surgery
hamstring strength	Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO	3 and 9 months after surgery
isokinetic quadriceps strength	Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO	3 and 9 months after surgery
Return to pre-injury level of sport	Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report	9 months after surgery

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Investigators: Principal Investigator: Jasper Most, Zuyderland Medisch Centrum; Study Director: Baris Koc, MD, PhDc, Zuyderland Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Blood Flow Restriction Therapy
• Other Study ID Numbers: NL83376.096.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be shared upon reasonable written request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No