Differences in Outcomes and Failure Rates Between Allografts and Autografts in Revision Anterior Cruciate Ligament Reconstruction

NCT07671235 | Not Yet Recruiting

• 1 other identifier: ACLREV_GRAFT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; Graft Failure

Outcome Measures

Primary Outcomes (1)

• 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

  At least 24 months after surgery

Secondary Outcomes (9)

• Lysholm Knee Score

  At least 24 months after surgery

• International Knee Documentation Committee - Objective Knee Evaluation Form

  At least 24 months after surgery

• Anterior drawer test

  At least 24 months after surgery

• Lachman test

  At least 24 months after surgery

• Pivot shift test

  At least 24 months after surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

stefano zaffagnini

CONTACT

0516366075; stefano.zaffagnini@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

IT (1)