Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique

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.

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^.

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.

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.

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).

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

tibial & femoral,

• Grade I, full attachment of a low-intensity signal band onto the bone tunnel with no fibrous tissue at the tendon-bone interface;
• Grade II, a low-intensity signal band with a partial high- intensity signal band at the tendon-bone interface;
• Grade III, the graft bone interface is filled with a continuous high- intensity signal band.

subjectively, tibial & femoral, of the applied autologous bone matrix

• Grade I, excellent integration indicating no space between the graft and osseous formation in the proximal and mid portion.
• Grade II, good integration indicating no space between the graft and osseous formation in the proximal or mid portion.
• Grade III, fair integration indicating a gap between the graft and osseous formation in the proximal and mid portion.
• Grade IV, poor integration indicating no osseous formation in the proximal and mid portion.

extension and flexion (°) both knees

Extension and Flexion (Nm), operated vs. non-operated side

balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial

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)

unilateral forward jump as far as possible (cm)

repeated side hops over a distance of 40 cm and back to start position (number of touch-downs within 30 seconds)

gait restrictions related to the operated knee (i.e. limping) (y/n)

procedure- and product-related adverse events will be described and given as frequency per type

standardized instrument for measuring generic health status regardless of existing diseases within five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), result is a 5-level health state

Quality of life, regardless of existing diseases, visual analogue scale from 0 - 100. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.

assess patient-relevant outcomes following knee injury using 42 items within 5 subscales, which are scored separately; each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

one-item score that grades activity based on work and sports activities on a scale of 0 (disability because of knee problems) to 10 (national or international elite level)

the patient's self-confidence and risk assessment regarding a return to sport after ACL reconstruction with 12 items using a numeric rating scale of 0 to 100.

unidimensional measure of pain intensity in adults, where 0=no pain and 10=worst possible pain