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 | Recruiting DMC

• 1 other identifier: ACL_REVISION_SBLP
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL; LET

Outcome Measures

Primary Outcomes (1)

• Lysholm Knee Score

  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).

  At least 24 months after surgery

Secondary Outcomes (11)

• Physical examination

  At least 24 months after surgery

• Anterior drawer test

  24 months after surgery

• Lachman test

  At least 24 months after surgery

• Pivot shift test

  At least 24 months after surgery

• International Knee Documentation Committee (IKDC)

  At least 24 months after surgery

Eligibility Criteria

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

Study Population

Patients will be recruited from all subjects who underwent revision of anterior cruciate ligament reconstruction with the single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft at the SC Orthopedic and Traumatology Clinic II of the Rizzoli Orthopedic Institute, at least 2 years after the surgical procedure and the clinical-radiological reassessment proposed in this study, between 1/1/2000 and 31/12/2022 at the Rizzoli Orthopedic Institute. This reassessment is part of standard clinical practice.

You may qualify if:

• Age between 18 and 50 years at the time of surgery;
• Male and female gender;
• 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;
• A radiograph taken immediately before or after the surgery of the affected knee;
• Patients who have provided consent to participate in the study.

You may not qualify if:

• Patients no longer accessible;
• Patients who deny consent to participate in the study;
• Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery;
• Severe obesity (BMI \> 35);
• Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment;
• Infection or hematological or rheumatic conditions at the time of the assessment.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

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

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

IT (1)