ACL InjuryACLREV_GRAFTNCT07671235
Differences in Outcomes and Failure Rates Between Allografts and Autografts in Revision Anterior Cruciate Ligament Reconstruction
An observational study of ACL Injury and Graft Failure, run by Stefano Zaffagnini at 1 site in Italy.
Trial summary
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries, particularly in young and physically active individuals. Despite advances in reconstruction techniques, graft failure and rerupture remain clinically relevant. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury, Graft Failure
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2026to May 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 among all subjects who underwent revision anterior cruciate ligament reconstruction at the SC Orthopaedic and Trauma Clinic II of the Istituto Ortopedico Rizzoli, with at least 2 years between the surgical procedure and the clinical-radiological reassessment proposed in this study, from 01/01/2016 to 31/12/2024 at the Istituto Ortopedico Rizzoli. Such reassessment is part of routine clinical practice.
Who may be able to join
- Age 18-50 years at the time of surgery
- Male and female patients
- Patients undergoing revision anterior cruciate ligament (ACL) reconstruction with possible associated procedures, with at least 2 years of follow-up
- Written informed consent to participate in the study
Who cannot join
- Patients lost to follow-up
- Refusal to provide informed consent
- Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery
- Severe obesity (BMI > 35)
- Lower limb conditions preventing full weight-bearing standing during evaluation
- Active infection, hematologic disease, or rheumatologic disease at the time of 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 Rizzoli Orthopedic Institute
Bologna, Bologna, 40136
stefano zaffagnini, 051636 ext. 6075, stefano.zaffagnini@ior.it
About this study
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries, particularly in young and physically active individuals. Despite advances in reconstruction techniques, graft failure and rerupture remain clinically relevant. Revision ACL surgery is more complex than primary reconstruction and is associated with inferior outcomes, with rerupture rates of approximately 13%, reaching up to 25% when both subjective and objective failure criteria are considered.
The main goal of ACL reconstruction is to restore anteroposterior and rotational knee stability, prevent secondary meniscal and cartilage damage, and enable return to sport. Surgical outcomes depend on several intraoperative factors, including graft choice and tunnel geometry, which are particularly relevant in revision settings.
Read more
Diagnosis of ACL rerupture is primarily clinical, based on instability tests (Lachman, anterior drawer, pivot shift), and supported by instrumental assessment such as the KT-1000 arthrometer, which provides an objective measure of joint laxity.
Revision ACL reconstruction can be performed using different surgical techniques (single-bundle, double-bundle, or combined extra-articular procedures) and graft types (autograft or allograft). Surgical strategy depends on multiple factors such as meniscal and cartilage status, previous surgery characteristics, tunnel positioning/enlargement, and fixation devices. However, no consensus exists regarding the optimal approach in terms of mid- to long-term outcomes.
A major long-term complication is the development of osteoarthritis, particularly in this typically young and active patient population. Identification of modifiable factors, such as surgical technique and graft type, may help reduce failure risk and joint degeneration.
This study aims to evaluate clinical and radiographic outcomes over a follow-up period exceeding two years in patients undergoing revision ACL reconstruction with different surgical techniques and graft types. The study also integrates objective knee laxity assessment using KT-1000 and markerless motion analysis based on artificial intelligence. Functional movements are recorded via video and analyzed using Sports2D software, enabling 2D kinematic analysis without markers or sensors, providing quantitative functional data to complement clinical and radiographic evaluation.
- Conditions
- ACL Injury, Graft Failure
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Failures will be recorded and documented in the case report form (CRF), during telephone questionnaires, and through the patient's clinical records (Electronic Health Record, SIR 2020, and hospital databases). The survival rate at follow-up will then be estimated using a Kaplan-Meier survival curve
Measured: At least 24 months after surgery
Secondary outcomes (9)
Lysholm Knee Score
It is a validated measurement scale that assesses knee function through 8 items, allowing evaluation of knee condition in relation to the functional demands of activities of daily living. This assessment form is used to evaluate surgical outcomes in patients undergoing surgery for ligamentous or meniscal knee injuries.
The final score is obtained by summing the scores of the individual items and ranges from 0 to 100. Scores are categorized into subgroups as follows: Excellent (95-100); Good (84-94); Fair (65-83); Poor (<64)
Measured: At least 24 months after surgery
International Knee Documentation Committee - Objective Knee Evaluation Form
The objective IKDC is a clinical assessment form completed by the investigator, which allows standardized classification of knee status through objective parameters. The evaluation is based on four main domains: joint effusion, range of motion, ligament stability (in particular Lachman test, pivot-shift test, and anterior/posterior drawer tests), and joint compartments (meniscal and ligament examination).
The final outcome is not expressed as a continuous numerical score, but rather as a classification into four categories:
A (Normal) B (Nearly normal) C (Abnormal) D (Severely abnormal)
The final classification corresponds to the worst score obtained among the evaluated domains.
Measured: At least 24 months after surgery
Anterior drawer test
It allows assessment of anterior tibial translation relative to the femur with the knee flexed at 90 degrees. An increased translation suggests a lesion of the reconstructed ACL (neo-ACL). It is graded on a scale from 0 to 3
Measured: At least 24 months after surgery
Lachman test
It allows assessment of anterior tibial translation relative to the femur with the knee flexed at 30 degrees. Increased translation suggests a lesion of the reconstructed ACL (neo-ACL). It is graded on a scale from 0 to 3
Measured: At least 24 months after surgery
Pivot shift test
This is a clinical examination maneuver used to assess rotational instability of the knee. The test is performed by applying a valgus and internal rotation stress during knee flexion; the occurrence of a tibial "shift" or "clunk" suggests a lesion of the reconstructed ACL (neo-ACL) associated with rotational instability. It is graded on a scale from 0 to 3.
Measured: At least 24 months after surgery
Tegner Activity Scale
The Tegner Score is a physical activity rating scale that measures the level of participation in occupational and sports activities. The score ranges from 0 to 10, where:
0 indicates inability to work or severe disability due to knee problems;
10 indicates participation in competitive sports at national or international level (e.g., professional football).
Intermediate levels describe progressively more demanding physical activities, distinguishing between activities of daily living, light or heavy work, and recreational or competitive sports.
The Tegner Score is frequently used in combination with other instruments (such as the IKDC or Lysholm scores) to define the patient's functional level before injury and after treatment. In the context of this study, the score is collected through a direct patient interview conducted by the investigator.
Measured: At least 24 months after surgery
WOMAC
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered questionnaire specifically developed to assess patients with hip and knee osteoarthritis. The instrument evaluates the impact of the disease on pain, stiffness, and physical function.
The questionnaire consists of 24 items divided into three main domains:
- Pain (5 items)
- Joint stiffness (2 items)
- Physical function (17 items)
The total score is normalized on a 0-100 scale.
Measured: At least 24 months after surgery
KT-1000
The KT-1000 is an objective assessment device that measures anterior tibial translation relative to the femur by applying a predefined force to translate the tibia anteriorly. Its use is part of routine clinical practice in the outpatient setting of the Second Orthopaedic and Trauma Clinic of the IOR and aims to quantitatively assess static anteroposterior knee laxity following anterior cruciate ligament reconstruction. The unit of measurement is millimetres
Measured: At least 24 months after surgery
Post-operative movement analysis
Knee function will be assessed during functional tasks (walking, lunges, squat) using a markerless AI-based video analysis system (Sports2D). The software estimates 2D joint kinematics (hip, knee, ankle, trunk) from videos recorded in frontal and sagittal planes without the use of sensors or markers. The system is non-invasive, already used in clinical practice, and installed locally to ensure data protection.
Videos are processed through an internal MATLAB script that extracts kinematic outputs (.mot and .trc files) using automated AI-based analysis. Data are anonymized via alphanumeric IDs, and videos are deleted after processing to minimize data retention.
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 posted26 Jun 2026
- Study start8 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Retrospective
- Enrolment
- 150 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
- NCT07671235
- Sponsor's protocol ID
- ACLREV_GRAFT
- Acronym
- ACLREV_GRAFT
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Outcomes and Failure Rates Between Allografts and Autografts in Revision Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07671235
- Acronym / sponsor ID
- ACLREV_GRAFT / ACLREV_GRAFT
- Conditions
- ACL Injury, Graft Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries, particularly in young and physically active individuals. Despite advances in reconstruction techniques, graft failure and rerupture remain clinically relevant. Revision ACL surgery is more complex than primary reconstruction and is associated with inferior outcomes, with rerupture rates of approximately 13%, reaching up to 25% when both subjective and objective failure criteria are considered.
The main goal of ACL reconstruction is to restore anteroposterior and rotational knee stability, prevent secondary meniscal and cartilage damage, and enable return to sport. Surgical outcomes depend on several intraoperative factors, including graft choice and tunnel geometry, which are particularly relevant in revision settings.
Diagnosis of ACL rerupture is primarily clinical, based on instability tests (Lachman, anterior drawer, pivot shift), and supported by instrumental assessment such as the KT-1000 arthrometer, which provides an objective measure of joint laxity.
Revision ACL reconstruction can be performed using different surgical techniques (single-bundle, double-bundle, or combined extra-articular procedures) and graft types (autograft or allograft). Surgical strategy depends on multiple factors such as meniscal and cartilage status, previous surgery characteristics, tunnel positioning/enlargement, and fixation devices. However, no consensus exists regarding the optimal approach in terms of mid- to long-term outcomes.
A major long-term complication is the development of osteoarthritis, particularly in this typically young and active patient population. Identification of modifiable factors, such as surgical technique and graft type, may help reduce failure risk and joint degeneration.
This study aims to evaluate clinical and radiographic outcomes over a follow-up period exceeding two years in patients undergoing revision ACL reconstruction with different surgical techniques and graft types. The study also integrates objective knee laxity assessment using KT-1000 and markerless motion analysis based on artificial intelligence. Functional movements are recorded via video and analyzed using Sports2D software, enabling 2D kinematic analysis without markers or sensors, providing quantitative functional data to complement clinical and radiographic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited among all subjects who underwent revision anterior cruciate ligament reconstruction at the SC Orthopaedic and Trauma Clinic II of the Istituto Ortopedico Rizzoli, with at least 2 years between the surgical procedure and the clinical-radiological reassessment proposed in this study, from 01/01/2016 to 31/12/2024 at the Istituto Ortopedico Rizzoli. Such reassessment is part of routine clinical practice.
Key inclusion criteria (4 listed)
- Age 18-50 years at the time of surgery
- Male and female patients
- Patients undergoing revision anterior cruciate ligament (ACL) reconstruction with possible associated procedures, with at least 2 years of follow-up
- Written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patients lost to follow-up
- Refusal to provide informed consent
- Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery
- Severe obesity (BMI > 35)
- Lower limb conditions preventing full weight-bearing standing during evaluation
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
Survival rate
Time frame: At least 24 months after surgery
Failures will be recorded and documented in the case report form (CRF), during telephone questionnaires, and through the patient's clinical records (Electronic Health Record, SIR 2020, and hospital databases). The survival rate at follow-up will then be estimated using a Kaplan-Meier survival curve
9 secondary outcomes
Lysholm Knee Score
Time frame: At least 24 months after surgery
International Knee Documentation Committee - Objective Knee Evaluation Form
Time frame: At least 24 months after surgery
Anterior drawer test
Time frame: At least 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
Tegner Activity Scale
Time frame: At least 24 months after surgery
WOMAC
Time frame: At least 24 months after surgery
KT-1000
Time frame: At least 24 months after surgery
Post-operative movement analysis
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 4 Aug 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 Injury and Graft Failure, 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 4 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 4 Aug 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?
Survival rate (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 4 Aug 2026.