NCT07671235 Differences in Outcomes and Failure Rates Between Allografts and Autografts in Revision Anterior Cruciate Ligament Reconstruction
| NCT ID | NCT07671235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stefano Zaffagnini |
| Condition | ACL Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-07-08 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07671235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07671235 currently recruiting?
Yes, NCT07671235 is actively recruiting participants. Contact the research team at stefano.zaffagnini@unibo.it for enrollment information.
Where is the NCT07671235 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07671235 clinical trial?
NCT07671235 is sponsored by Stefano Zaffagnini. The trial plans to enroll 150 participants.