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临床试验/NCT07671235
NCT07671235招募中不适用

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

Stefano Zaffagnini2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Survival rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Survival rate

时间窗: 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

次要结局

  • 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)
  • Tegner Activity Scale(At least 24 months after surgery)
  • WOMAC(At least 24 months after surgery)
  • KT-1000(At least 24 months after surgery)
  • Post-operative movement analysis(At least 24 months after surgery)

研究者

发起方
Stefano Zaffagnini
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

研究点 (2)

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