Clinical trial NCT06868147: Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.
Official title: Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using Over The Top Single-bundle Technique and Lateral Extra-articular Tenodesis With Achilles Tendon Allograft.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ACL
LET
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Lysholm Knee Score
timeFrame: At least 24 months after surgery
Secondary outcomes:
measure: Physical examination
timeFrame: At least 24 months after surgery
measure: Anterior drawer test
timeFrame: 24 months after surgery
measure: Lachman test
timeFrame: At least 24 months after surgery
measure: Pivot shift test
timeFrame: At least 24 months after surgery
measure: International Knee Documentation Committee (IKDC)
timeFrame: At least 24 months after surgery
measure: VAS
timeFrame: At least 24 months after surgery
measure: Tegner score
timeFrame: At least 24 months after surgery
measure: PASS score
timeFrame: At least 24 months after surgery
measure: Weight-bearing X-ray of the operated knee (Kellgren-Lawrence scale).
timeFrame: At least 24 months after surgery
measure: KT-1000
timeFrame: At least 24 months after surgery
measure: KYRA
timeFrame: At least 24 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: