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

NCT ID: NCT06868147

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2027-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

stefano zaffagnini

Role: CONTACT

stefano.zaffagnini@unibo.it

0516366075

Facility Contacts

Stefano Zaffagnini

Role: primary

stefano.zaffagnini@ior.it

051636 ext. 6075

Other Identifiers

ACL_REVISION_SBLP

Identifier Type: -

Identifier Source: org_study_id