Anterior cruciate ligament (ACL) reconstruction is a widely performed procedure aimed at restoring knee stability and enabling return to sports activities. The Over-The-Top (OTT) technique is a well-established option, particularly in complex and revision cases, due to its ability to provide both anteroposterior and rotational stability. Long-term studies have reported favorable clinical outcomes, with low failure rates.
Graft fixation is an important technical aspect that may influence postoperative outcomes. Traditionally, the OTT technique has been performed using metal staples, which provide reliable primary fixation but may cause local complications and sometimes require subsequent removal due to pain or discomfort.
More recently, suture-based fixation devices, such as Knee FiberTak anchors (Arthrex), have been introduced as a metal-free alternative. These devices allow graft fixation through high-strength sutures, providing stable graft-to-bone contact while minimizing bony invasiveness and hardware prominence.
The present study aims to evaluate the clinical, functional, and instrumental outcomes of ACL reconstruction using the OTT technique with graft fixation by suture anchors compared with traditional metal staples. Particular attention will be paid to postoperative knee stability, assessed using validated instruments (KT-1000 and KiRA), as well as failure rates, reoperations, and complications.
Patients of either sex, aged between 18 and 50 years at the time of surgery;
Patients with an isolated anterior cruciate ligament (ACL) injury, with or without associated meniscal lesions, scheduled for ACL reconstruction and meniscal treatment; .3 Patients whose contralateral knee has never undergone meniscectomy, ligament reconstruction, unicompartmental knee arthroplasty, or total knee arthroplasty;
Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL);
Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT);
Patients who underwent total or subtotal medial or lateral meniscectomy;
Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery;
Parallel
ACL reconstruction using the Over-The-Top technique
Procedure/SurgeryThe procedure involves ACL reconstruction using the Over-The-Top technique, with the graft positioned over the lateral femoral condyle to provide anteroposterior and rotational stability. The graft is secured using either metal staples or suture anchors, according to the assigned fixation technique.
KT-1000
The KT-1000 is a clinical-instrumental test widely used for the standardized assessment of patients undergoing anterior cruciate ligament (ACL) reconstruction. It provides an objective measurement of anterior-posterior knee laxity and is extensively used in both clinical practice and scientific research. The assessment is performed with the patient in a supine position, with the knee flexed to approximately 30° and supported on a dedicated device. The examiner applies a standardized anterior load to the tibia while stabilizing the femur, and the resulting anterior-posterior displacement is recorded by sensors positioned in contact with the patella and tibial tuberosity. The measurement does not have a predefined minimum or maximum value. Lower values indicate less anterior laxity and therefore better knee stability, whereas higher values indicate greater anterior laxity and worse knee stability.
KiRA
For quantitative assessment of the Pivot Shift test, the KiRA sensor is secured to the skin over the anterolateral proximal tibia, specifically at the level of Gerdy's tubercle, using a hypoallergenic strap and an appropriate support to optimize stability. The device, which incorporates a triaxial accelerometer and gyroscope, communicates wirelessly with a dedicated application installed on a tablet, providing real-time quantification of tibial displacement during the clinical maneuver. KiRA measurements are expressed in millimeters (mm) and represent the magnitude of anterior tibial displacement. There is no predefined minimum or maximum value for this continuous measurement; lower values indicate less tibial displacement and therefore better rotational stability, whereas higher values indicate greater displacement and worse rotational stability.
IKDC standard evaluation form
This is a clinical assessment form completed by the physician following a thorough physical examination of the knee. It includes several clinical tests to assess joint deformities, objective instability, and meniscal injuries. The resulting score determines an objective functional grade, classified from A to D: \*\*A\*\*, normal; \*\*B\*\*, nearly normal; \*\*C\*\*, moderately abnormal; and \*\*D\*\*, severely abnormal.
Lysholm Knee Score
This is a validated outcome measure that assesses knee function through 8 items designed to evaluate the knee's ability to meet the functional demands of daily activities. It is commonly used to assess surgical outcomes in patients undergoing treatment for knee ligament or meniscal injuries. The final score is calculated by summing the scores obtained across the individual items, ranging from 0 to 100. Scores are classified as \*\*Excellent (95-100), Good (84-94), Fair (65-83), and Poor (\<64)\*\*.
VAS
This is a 10-point unidimensional numerical scale used to assess pain intensity. The patient selects the number that best represents their pain intensity at that specific moment, ranging from 0 (no pain) to 10 (worst possible pain)
Click on the lead sponsor to view all of their trials.
Stefano Zaffagnini
Lead sponsor
Istituto Ortopedico Rizzoli
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
