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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05972876
Other study ID # NL83376.096.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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