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

NCT07049484 | Recruiting

• 1 other identifier: LETOTT
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Reconstruction; Tenodesis; ACL Injuries

Outcome Measures

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.

  12 months

Secondary Outcomes (10)

• KT-1000 Arthrometer

  12 months

• Physical Examination

  12 months

• Anterior Drawer Test

  12 months

• Lachman Test

  12 months

• Pivot Shift Test

  12 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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…).
• Patients who did not provide informed consent.

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

stefano zaffagnini

CONTACT

0516366075; stefano.zaffagnini@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: March 24, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

IT (1)