ACLACL_REVISIONNCT06868147
Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.
An observational study of ACL and LET, run by Stefano Zaffagnini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Zaffagnini, 051636 ext. 6075, stefano.zaffagnini@ior.it
About this study
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.
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At least 24 months after surgery
Secondary outcomes (11)
Physical examination
A standard physical examination will be performed, and the classic painful points related to meniscal pathology will be assessed.
Measured: At least 24 months after surgery
Anterior drawer test
it allows the assessment of the anterior translation of the tibia relative to the femur with the knee flexed at 90 degrees. An increase in this translation suggests a lesion of the neo-ACL. It is quantified on a scale from 0 to 3.
Measured: 24 months after surgery
Lachman test
it allows the assessment of the anterior translation of the tibia relative to the femur with the knee flexed at 30 degrees. An increase in this translation suggests a lesion of the neo-ACL. It is quantified on a scale from 0 to 3.
Measured: At least 24 months after surgery
Pivot shift test
it is a clinical maneuver used to assess the rotational instability of the knee under examination. The test is performed by applying a stress in internal rotation-valgus and flexion; the occurrence of a "shift" or "clunk" of the tibia suggests a lesion of the neo-ACL associated with rotational instability. It is quantified on a scale from 0 to 3.
Measured: At least 24 months after surgery
International Knee Documentation Committee (IKDC)
The IKDC form is a subjective knee assessment tool that expresses the limitations in the activities the individual can perform in daily life and sports, as well as the presence or absence of symptoms. The three main domains of the IKDC assessment form are: Symptoms, which include pain, stiffness, swelling, and a feeling of locking; Sports and daily activities; Current knee function and function before the injury.
Measured: At least 24 months after surgery
VAS
It is a 10-point unidimensional quantitative pain assessment scale; the scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that specific moment. 0 means no pain, and 10 indicates the worst possible pain.
Measured: At least 24 months after surgery
Tegner score
It allows the estimation of a subject's level of physical activity with a score between 0 and 10, where 0 represents 'incapacity' and 10 represents 'participation in competitive sports, such as national or international-level football.' This score is the most commonly used to define the level of physical activity in patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview with the patient.
Measured: At least 24 months after surgery
PASS score
In order to assess the patient's level of satisfaction, they will be asked to answer the question "Are you satisfied with the surgical intervention?" The response will be dichotomous.
Measured: At least 24 months after surgery
Weight-bearing X-ray of the operated knee (Kellgren-Lawrence scale).
For the radiographic assessment, the patient's clinical and radiological data will be collected, and if necessary, X-rays will be performed to evaluate the development and degree of osteoarthritis, using the Kellgren-Lawrence scale. This scale classifies osteoarthritis into 5 grades, from no arthritic changes (grade 0) to severe joint space narrowing and osteophyte formation (grade 4).
Measured: At least 24 months after surgery
KT-1000
The KT-1000 is an objective assessment tool that measures the anterior tibial translation relative to the femur's position by applying a predefined force to push the tibia forward. It is commonly used in research to quantitatively assess the static laxity of the knee in the anteroposterior direction after anterior cruciate ligament reconstruction surgeries.
Measured: At least 24 months after surgery
KYRA
KYRA is a non-invasive, outpatient device that allows the assessment of dynamic laxity during the pivot shift phenomenon. The device quantifies the degree of laxity with extreme precision. The unit of measurement is millimeters per square second.
Measured: At least 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start19 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868147
- Sponsor's protocol ID
- ACL_REVISION_SBLP
- Acronym
- ACL_REVISION
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06868147
- Acronym / sponsor ID
- ACL_REVISION / ACL_REVISION_SBLP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lysholm Knee Score
Time frame: 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).
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL and LET, run by Stefano Zaffagnini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact stefano zaffagnini (0516366075, stefano.zaffagnini@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score (time frame: At least 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.