Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ACL, LET. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Primary outcome measures
- Lysholm Knee Score [Time frame: At least 24 months after surgery]
Secondary outcome measures (11)
- Physical examination [Time frame: At least 24 months after surgery]
- Anterior drawer test [Time frame: 24 months after surgery]
- Lachman test [Time frame: At least 24 months after surgery]
- Pivot shift test [Time frame: At least 24 months after surgery]
- International Knee Documentation Committee (IKDC) [Time frame: At least 24 months after surgery]
- VAS [Time frame: At least 24 months after surgery]
- Tegner score [Time frame: At least 24 months after surgery]
- PASS score [Time frame: At least 24 months after surgery]
- Weight-bearing X-ray of the operated knee (Kellgren-Lawrence scale). [Time frame: At least 24 months after surgery]
- KT-1000 [Time frame: At least 24 months after surgery]
- KYRA [Time frame: At least 24 months after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06868147 · ACL_REVISION_SBLP