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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-00168 | Other Identifier | BASEC |
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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.
To be successful, an ACL reconstruction requires a strong incorporation of the tendon to the bone within or at the margin of the tunnel, but the tunnel itself is at risk of widening, therefore compromising the tendon attachment. A composite of harvested healthy autologous bone fragments from the tunnel and autologous thrombin and fibrin, generated from the patient's PrP could be used at the interface between tunnel and ACL graft at the tibia and femur to reduce frequency of tunnel widening and therefore improve graft-bone-integration.
The study seeks primarily to determine less tibial tunnel widening when a bone/PrP-composite is applied directly in the tibial tunnel compared to the same surgery without using the composite, measured with CT and MRI.
Secondary study objectives are to evaluate femoral tunnel widening, tibial and femoral graft incorporation, graft maturation and knee function (clinical, functional, patient reported) over the course of 24 months follow-up and to evaluate occurrence of procedure- and product-related adverse events and complications.
This is a prospective, single-center, single-blinded, 2-arm-parallel, randomized, controlled study with 24 months follow-up. Participants will be recruited from the Knee Surgery department at Schulthess Klinik when scheduled for ACL reconstruction. The study sample comprises 107 patients, allocated 1:1 on experimental and control arm. Outcome measures are taken at 0, 6, 12, and 24 months. The total study duration is 48 months. The study duration per patient is 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACLr with bone/PrP-composite | Experimental | During surgery, 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. |
|
| ACLr standard | Active Comparator | No insertion of additional material after ACL graft fixation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction with bone/PrP-composite | Procedure | During 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 to 14 months post-surgery |
| 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^. | 10 to 14 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | extension and flexion (°) both knees | 10-14 and 20-28 months post-surgery |
| Isokinetic knee strength test | Extension and Flexion (Nm), operated vs. non-operated side |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent A Stadelmann, PhD | Contact | +41 44 385 | 75 87 | vincent.stadelmann@kws.ch |
| Anika Stephan, MA | Contact | +41 44 385 | 79 84 | anika.stephan@kws.ch |
| Name | Affiliation | Role |
|---|---|---|
| Gian Salzmann, Prof. | Schulthess Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Recruiting | Zurich | 8008 | Switzerland |
When published, authors will make their data available upon reasonable request or according to the guidelines of the journal.
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Patients will be allocated 1:1 on experimental and control arm using block randomization within both genders with random block sizes (randomly chosen from the set [2,4,6,8]).
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Patients are blinded. As well, staff conducting and evaluating MRI, clinical evaluation, CT and functional tests are blinded.
|
| ACL reconstruction (Standard) | Procedure | Standard 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 |
|
| 10 to 14 months post-surgery |
| 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. | 10 to 14 months post-surgery |
| Graft maturity_subj | tibial & femoral, subjectively, using a 4-grade system MRI after 12 months based on Proton-density-weighted images
| 10 to 14 months post-surgery |
| 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 | 10 to 14 months post-surgery |
| Graft integration | tibial & femoral,
| 10 to 14 months post-surgery |
| Bone healing and integration | subjectively, tibial & femoral, of the applied autologous bone matrix
| 10 to 14 months post-surgery |
| 10-14 and 20-28 months post-surgery |
| 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 | 10-14 and 20-28 months post-surgery |
| 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) | 10-14 and 20-28 months post-surgery |
| Front hop | unilateral forward jump as far as possible (cm) | 10-14 and 20-28 months post-surgery |
| Side hop | repeated side hops over a distance of 40 cm and back to start position (number of touch-downs within 30 seconds) | 10-14 and 20-28 months post-surgery |
| gait restrictions | gait restrictions related to the operated knee (i.e. limping) (y/n) | 10-14 and 20-28 months post-surgery |
| adverse events | procedure- and product-related adverse events will be described and given as frequency per type | 10-14 and 20-28 months post-surgery |
| European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | 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 | -3 to 0, 6, 12, 24 months post-surgery |
| EuroQol visual analogue scale (EQ-VAS) | 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. | -3 to 0, 6, 12, 24 months post-surgery |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | -3 to 0, 6, 12, 24 months post-surgery |
| Tegner Activity Scale | 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) | 12, 24 months post-surgery |
| Return to Sport Injury Scale (ACL-RSI) | 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. | 12, 24 months post-surgery |
| Numeric Rating scale for pain (NRS) in the knee | unidimensional measure of pain intensity in adults, where 0=no pain and 10=worst possible pain | -3 to 0, 6, 12, 24 months post-surgery |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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