An interventional study of ACL reconstruction using the Over-The-Top technique in ACL Reconstruction and Fixation, sponsored by Stefano Zaffagnini. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Stefano Zaffagnini · Not applicable, Interventional, and Treatment
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.
Stefano Zaffagnini is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: ACL reconstruction using the Over-The-Top technique
Procedure: ACL reconstruction using the Over-The-Top technique
The 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.
Time frame: At least 24 months
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.
Time frame: At least 24 months
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.
Time frame: At least 24 months
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)\*\*.
Time frame: At least 24 months
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)
Time frame: At least 24 months
SF-12 (Short Form-12 Health Survey)
This is a 12-item multiple-choice questionnaire that provides two main summary measures: the \*\*Physical Component Summary (PCS)\*\* and the \*\*Mental Component Summary (MCS)\*\*. Together, these scores provide a concise and reliable assessment of the patient's overall health status. Scores are typically reported on a 0-100 scale, with higher scores indicating better health-related quality of life.
Time frame: At least 24 months
KOOS (Knee Injury and Osteoarthritis Outcome Score)
This is a validated, knee-specific outcome measure used to assess symptoms and function in patients with ligament injuries or degenerative knee conditions. It consists of five subscales: \*\*Pain, Other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life (QOL)\*\*, providing a comprehensive assessment of the impact of knee pathology and treatment on joint function and quality of life. Each subscale is scored from 0 to 100, with higher scores indicating better knee function and fewer symptoms, while lower scores indicate worse outcomes.
Time frame: At least 24 months
Tegner Score
The Tegner Activity Scale is a validated measure used to assess the patient's level of physical activity on a scale from \*\*0 to 10\*\*, where 0 represents disability and 10 represents participation in competitive sports at a national or international level, such as football. It is widely used to assess activity levels in patients with knee disorders. Patients will also be asked how many years they have been physically active in sports and whether any reduction or cessation of sporting activity is related to their knee condition.
Time frame: At least 24 months
Patient Satisfaction
To assess the patient's level of satisfaction, patients will be asked the following question: "Are you satisfied with the surgical procedure?" The response will be dichotomous (yes/no)
Time frame: At least 24 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Stefano Zaffagnini