Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorStefano Zaffagnini

About this trial

The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee joint, and its injury is among the most common soft tissue injuries of the knee. Several surgical reconstruction techniques are available, utilizing various tissues as a graft for the neo-ligament, including both autografts and allografts.

The "Over-the-top single-bundle technique with gracilis and semitendinosus tendons combined with lateral extra-articular tenodesis (LET)" was developed in 1998 by Prof. Marcacci and Prof. Zaffagnini, and it is still the preferred method for ACL reconstruction at the Second Clinic of the Rizzoli Orthopaedic Institute.

Cadaveric biomechanical studies have shown that combining LET with ACL reconstruction improves knee joint stability in both the anteroposterior and rotational planes. However, a recent in vivo study has challenged this hypothesis, showing that in patients undergoing surgery, the addition of LET enhances knee stability only in the anteroposterior direction and only for a limited period of six months. At twelve months postoperatively, joint laxity appeared similar to that of patients who did not undergo the additional procedure. Furthermore, the same study did not assess rotational instability using the pivot-shift test, an essential parameter as it is closely linked to knee stability and the patient's subjective perception of surgical success.

Despite the increasing use of LET in conjunction with ACL reconstruction, few studies have analyzed the short-term postoperative effects of lateral extra-articular tenodesis and its potential benefits during the early stages of rehabilitation and return to sport.

This study was conceived in response to this clinical question, with the goal of evaluating anteroposterior and rotational laxity in a group of patients who underwent ACL reconstruction combined with LET, in order to analyze clinical outcomes and, most importantly, any changes in stability during the early postoperative period.

The results aim to improve understanding of knee stability in the initial phase following surgery, providing valuable information for rehabilitation teams to optimize recovery protocols and more effectively guide return-to-sport decisions for patients undergoing both procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing isolated ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top technique and LET.

Both male and female patients.

Patients who have given consent to participate in the study.

Age between 18 and 50 years at the time of surgery.

Disqualifiers

Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, displaced fractures).

Surgical technique different from Over-the-Top with LET using autologous gracilis and semitendinosus tendons.

Other concomitant ligament injuries requiring surgical treatment.

Patients undergoing additional procedures at the same time as ACL reconstruction and LET (e.g., concomitant osteotomy, meniscus transplant, cartilage procedure…).

Trial population

Patients will be recruited from those surgically treated at the Second Clinic of the Rizzoli Orthopaedic Institute, undergoing anterior cruciate ligament reconstruction using the "over-the-top" single-bundle technique with gracilis and semitendinosus tendons, combined with lateral extra-articular tenodesis (LET). Only patients with at least 6 months of follow-up after the surgery date will be enrolled. Subsequently, patients will be re-evaluated during a 12-month follow-up visit, as per standard clinical practice for this procedure.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

KYRA accelerometer

KYRA is a non-invasive outpatient device that allows the assessment of dynamic laxity during the pivot shift phenomenon. The device enables highly precise quantification of the degree of laxity. The unit of measurement is millimeters per second squared.

Time frame
12 months

Secondary outcomes

1

KT-1000 Arthrometer

The KT-1000 is an objective assessment tool that measures anterior tibial translation relative to the position of the femur by applying a predefined force that pushes the tibia forward. It is commonly used in research settings to quantitatively evaluate static anteroposterior knee laxity following anterior cruciate ligament reconstruction surgeries.

Time frame
12 months
2

Physical Examination

A standard physical examination will be performed, including palpation, assessment of joint mobility, and laxity. During palpation, the typical tender points related to meniscal pathology are examined: the joint line areas on their anterior, middle, and posterior aspects. Pain is recorded as either present or absent. Joint mobility is assessed by asking the patient to flex and extend the knee, measuring the angle formed in degrees (0-130), with attention to the presence or absence of any joint clicks or catches. Laxity is evaluated using the classic tests: anterior drawer test, Lachman test, and pivot shift test.

Time frame
12 months
3

Anterior Drawer Test

This test allows evaluation of the anterior translation of the tibia relative to the femur with the knee flexed at 90 degrees. An increased translation suggests a lesion of the reconstructed ACL (neo-ACL). The degree of translation is quantified on a scale from 0 to 3.

Time frame
12 months
4

Lachman Test

This test allows evaluation of the anterior translation of the tibia relative to the femur with the knee flexed at 30 degrees. An increased translation suggests a lesion of the reconstructed ACL (neo-ACL). It is quantified on a scale from 0 to 3.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stefano Zaffagnini

Lead sponsor

Istituto Ortopedico Rizzoli

Sponsor institution