ACL Reconstruction, Fixation
Conditions
Brief summary
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.
Interventions
PROCEDUREACL 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.
Sponsors
Stefano Zaffagnini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of either sex, aged between 18 and 50 years at the time of surgery; 2. 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; 4\. Patients who have signed the informed consent form.
Exclusion criteria
1. Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL); 2. Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT); 3. Patients who underwent total or subtotal medial or lateral meniscectomy; 4. Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery; 5. Patients who are unable to provide informed consent or who are unwilling to provide informed consent; 6. Patients with insufficient and/or compromised bone quality or quantity due to disease, infection, or previous implantation, such that adequate support and/or fixation of the devices cannot be ensured; 7. Patients with limited blood supply or a history of infections that could delay healing; 8. Patients with sensitivity to foreign materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KT-1000 | At least 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KiRA | At least 24 months | 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 | At least 24 months | 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 | At least 24 months | 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 | At least 24 months | 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) |
| SF-12 (Short Form-12 Health Survey) | At least 24 months | 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. |
| KOOS (Knee Injury and Osteoarthritis Outcome Score) | At least 24 months | 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. |
| Tegner Score | At least 24 months | 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. |
| Patient Satisfaction | At least 24 months | 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) |
Countries
Italy
Contacts
CONTACTStefano Zaffagnini
Outcome results
None listed