Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

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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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05972876
• Other study ID #: NL83376.096.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: Zuyderland Medisch Centrum
• Contact: Jasper Most, PhD
• Phone: 0031625159747
• Email: j.most[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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
• Resistance training
Resistance training will be performed without any blood flow restriction

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Range of motion	Range of motion will be evaluated with the use of a goniometer.	3 and 9 months after surgery
Secondary	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
Secondary	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
Secondary	Knee pain and function	Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)	3 and 9 months after surgery
Secondary	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
Secondary	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
Secondary	hamstring strength	Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO	3 and 9 months after surgery
Secondary	isokinetic quadriceps strength	Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO	3 and 9 months after surgery
Secondary	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