The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture.
The main question to be answered is:
\- Does less widening of the tibial tunnel occur when a bone/Platelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)?
Participants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.
Age 18-50 years
Primary ACL rupture
Time from injury to surgery: 4 weeks to 6 months
Single ACL rupture (isolated rupture)
Concomitant ligamentous instability/rupture
Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
Requirement for cartilage invasive treatment (debridement accepted)
Osteoarthritis at index knee joint
Parallel
ACL reconstruction with bone/PrP-composite
Procedure/SurgeryDuring standard ACL reconstruction, the drilled bone debris is collected in a sterile filtered chamber. Then the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.
ACL reconstruction (Standard)
Procedure/SurgeryStandard ACL reconstruction with Semitendinosus alone or plus gracilis, femoral fixation via extracortical fixation by adjustable loop device, tibial fixation via a bio-interference screw or adjustable device
Tibial tunnel diameter change
Diameter (mm) change of tibial tunnel in relation to tunnel diameter reported from surgery; assessed by one radiologist (CT); CT scanning is performed from a level just above the femoral external foramen to a level below the outer hole of the tibial tunnel in order to visualise the positioning of the autograft-fixing metallic devices. The scan is aligned so that the tunnel axis is in the sagittal plane. The diameter of the headed reamer that drilled the tibial tunnel is defined as the baseline diameter of the tibial tunnel (D0). Measurements are taken at 4 different levels for the tibial tunnels using 3D Multiplanar reconstruction. All diameters are calculated in mm within the measurement function of the picture archiving system. The percentage of widening is defined as the difference between initial drilling diameter D0 (derived from surgery report) and post-op measurements D12 in relation to initial drilling diameter D0.
Tibial tunnel volume change
Volume (mm\^3) change of tibial tunnel in relation to tunnel volume reported from surgery; assessed by one radiologist (CT); the border of the bone tunnel is drawn manually on every fourth slice in both the coronal plane and the sagittal plane and interpolated automatically in between. Based on the contours in those two planes, the contours in the axial plane are interpolated automatically into a 3D mask. The volume of the bone tunnel is determined by automatic voxel counting\^.
Femoral tunnel diameter change
Diameter (mm) change of femoral tunnel in relation to tunnel diameter reported from surgery; assessed by one radiologist (CT); CT scanning is performed from a level just above the femoral external foramen to a level below the outer hole of the tibial tunnel in order to visualise the positioning of the autograft-fixing metallic devices. The scan is aligned so that the tunnel axis is in the sagittal plane. The diameter of the headed reamer that drilled the femoral tunnel is defined as the baseline diameter of the femoral tunnel (D0). Measurements are taken at 4 different levels for the femoral tunnels using 3D Multiplanar reconstruction. All diameters are calculated in mm within the measurement function of the picture archiving system. The percentage of widening is defined as the difference between initial drilling diameter D0 (derived from surgery report) and post-op measurements D12 in relation to initial drilling diameter D0.
Femoral tunnel volume change
Volume (mm\^3) change of femoral tunnel in relation to tunnel volume reported from surgery; assessed by one radiologist (CT); the border of the bone tunnel is drawn manually on every fourth slice in both the coronal plane and the sagittal plane and interpolated automatically in between. Based on the contours in those two planes, the contours in the axial plane are interpolated automatically into a 3D mask. The volume of the bone tunnel is determined by automatic voxel counting.
Graft maturity_subj
tibial \& femoral, subjectively, using a 4-grade system MRI after 12 months based on Proton-density-weighted images * Grade 1 signal ("normal"): when the entire segment of graft has a homogeneous, low intensity signal indistinguishable from that of the posterior cruciate ligament * Grade 2: if the segment of graft retained at least 50% of "normal" ligament signal intermixed with portions of the graft that had become edematous, as indicated by areas of increased signal intensity * Grade 3: when a segment of graft had \~50% of its area exhibiting a normal appearing ligament signal * Grade 4: diffuse increase in signal intensity with no normal-looking strands of ligament (100% oedematous).
Graft maturity_obj
objectively, within the tibial and femoral tunnels and in the intra-articular portion using the mean intensity of a region of interest on MRI to estimate the graft signal to noise quotient (SNQ) in comparison to the quadriceps tendon: SNQ = Signal intensity graft - Signal intensity quadriceps tendon / SI background
Range of motion
extension and flexion (°) both knees
Isokinetic knee strength test
Extension and Flexion (Nm), operated vs. non-operated side
Y-balance test
balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial
Knee Laxity
the patient is placed in the supine position on an examination table, the knees remain at approximately 30° of flexion and the tibia a 15° rotation. The displacement is consequently measured with the KT-1000 arthrometer device, calculating the relative motion between the sensor pad on the patella and the sensor pad on the anterior tibia under 67, 89 and 134 N force. The healthy leg is always to be tested first followed by the injured leg. The side-to-side differences are then evaluated at each force (mm)
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