Clinical trial NCT05972876: Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
Official title: MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Bone-Patellar Tendon-Bone Grafting
Keywords: Blood Flow Restriction Therapy
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Graft Maturity
timeFrame: 3 and 9 months after surgery
Secondary outcomes:
measure: Range of motion
timeFrame: 3 and 9 months after surgery
measure: Knee stability
timeFrame: 3 and 9 months after surgery
measure: Anterior knee pain
timeFrame: 3 and 9 months after surgery
measure: Knee pain and function
timeFrame: 3 and 9 months after surgery
measure: Knee function
timeFrame: 3 and 9 months after surgery
measure: patient confidence
timeFrame: 3 and 9 months after surgery
measure: hamstring strength
timeFrame: 3 and 9 months after surgery
measure: isokinetic quadriceps strength
timeFrame: 3 and 9 months after surgery
measure: Return to pre-injury level of sport
timeFrame: 9 months after surgery
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
affiliation: Zuyderland Medisch Centrum
name: Jasper Most
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland Medisch Centrum
name: Baris Koc, MD, PhDc
role: STUDY_DIRECTOR
References: