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Clinical Trials in Italy / NCT06868147
Recruiting Observational

Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.

NCT06868147 · tracked via the Priya Life Science Italy tracker
Sponsor
Stefano Zaffagnini
Phase
Observational
Started
2025-03-19
Last updated
2026-07-02

Condition(s) studied

ACLLET

Study summary

Several techniques for revision of anterior cruciate ligament (ACL) reconstruction and different types of grafts have been used over the years. These include single-bundle techniques, double-bundle techniques, and single-bundle techniques with external tenodesis. We also distinguish between the use of autografts and grafts from donors, or allografts.

The choice of surgical technique and graft type is strongly influenced by the progression of damage characterizing these patients (meniscal, chondral, or ligamentous), the surgical decisions made during the initial surgery (graft used, orientation, and number of bone tunnels), or any complications that occurred.

The use of a specific type of graft is heavily dependent on its availability: it is likely that the first-choice graft for some surgeons may be unavailable because it has already been used. The use of allografts is now commonly accepted by the scientific community, with the Achilles tendon standing out for its biomechanical properties and size. Unlike autografts, it does not damage the patient's ligamentous tissue, which is thus preserved.

Since osteoarthritis is one of the most debated consequences of anterior cruciate ligament revision, an analysis of the results is essential to provide a clearer understanding of the risks and benefits associated with the different types of procedures.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 and 50 years at the time of surgery; 2. Male and female gender; 3. Patients who have undergone revision of anterior cruciate ligament reconstruction with a single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft, with or without associated procedures, at least 2 years post-surgery; 4. A radiograph taken immediately before or after the surgery of the affected knee; 5. Patients who have provided consent to participate in the study. Exclusion Criteria: 1. Patients no longer accessible; 2. Patients who deny consent to participate in the study; 3. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery; 4. Severe obesity (BMI \> 35); 5. Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment; 6. Infection or hematological or rheumatic conditions at the time of the assessment.

Primary outcome measure(s)

  • Lysholm Knee Score — At least 24 months after surgery
    It is a validated measurement scale that assesses knee functionality through 8 items, allowing the evaluation of the knee's condition in relation to the functional demands of daily activities. This assessment tool is used to evaluate the outcomes of surgery in patients who have undergone surgery for ligamentous or meniscal knee injuries. The final score is obtained by summing the various scores from the different items, ranging from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Italy Recruiting

More Stefano Zaffagnini trials in Italy

Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET) Recruiting
Biological Evaluation of Orthopedic Materials: An In Vitro Study Using Patient-Derived Human Samples Starting soon
Outcomes and Complication Rates of Anterior Cruciate Ligament Reconstruction Using the "Over-the-top" Technique Combined With Lateral Extra-articular Tenodesis in Patients Over 50 Years Old, Compared With a Control Group of Patients Under 30 Recruiting
Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures Recruiting
Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training Recruiting

Other trials for the same condition

Outcomes and Complication Rates of Anterior Cruciate Ligament Reconstruction Using the "Over-the-top" Technique Combined With Lateral Extra-articular Tenodesis in Patients Over 50 Years Old, Compared With a Control Group of Patients Under 30 Recruiting
Anterior Cruciate Ligament Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868147 on ClinicalTrials.gov ↗ ← All trials in Italy