Anterior Cruciate Ligament Reconstruction, Bone-Patellar Tendon-Bone Grafting
Conditions
Keywords
Blood Flow Restriction Therapy
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.
Interventions
BEHAVIORALBlood flow restriction training
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
BEHAVIORALResistance training
Resistance training will be performed without any blood flow restriction
Sponsors
Zuyderland Medisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Maturity | 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
| Measure | Time frame | Description |
|---|---|---|
| Knee stability | 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 |
| Anterior knee pain | 3 and 9 months after surgery | anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain |
| Knee pain and function | 3 and 9 months after surgery | Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome) |
| Knee function | 3 and 9 months after surgery | knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome |
| Range of motion | 3 and 9 months after surgery | Range of motion will be evaluated with the use of a goniometer. |
| hamstring strength | 3 and 9 months after surgery | Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO |
| isokinetic quadriceps strength | 3 and 9 months after surgery | Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO |
| Return to pre-injury level of sport | 9 months after surgery | Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report |
| patient confidence | 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 |
Countries
Netherlands
Contacts
Primary ContactJasper Most, PhD
Outcome results
None listed