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临床试验/NCT07289412
NCT07289412招募中不适用

Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction

Stefano Zaffagnini1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Survival rate

研究概览

简要总结

Meniscal tears are among the most common injuries of the knee joint. The average annual incidence is between 60 and 70 cases per 100,000 people. Among young athletes, these injuries account for 20-30% of all knee injuries, while in individuals over 50 they are frequently present even without symptoms (up to 60%). Meniscal tears often coexist with other intra-articular injuries: about one third of all cases occur together with an ACL rupture, which significantly increases the likelihood of a meniscal lesion. Possible treatments range from total meniscectomy, partial or selective meniscectomy, to meniscal suturing.

Compared with meniscectomy, meniscal repair preserves meniscal function and reduces the risk of progression to knee osteoarthritis from 51.42% (after meniscectomy) to 21.28% in patients who undergo meniscal repair. The main meniscal suture techniques are classified as inside-out, outside-in, and all-inside.

The present study aims to analyze the failure rates in patients who underwent meniscal repair using the all-inside technique at a single referral center, evaluating the complication rate, the need for reoperation, and the clinical satisfaction of the operated patients.

The results obtained aim to improve the understanding of the effectiveness of all-inside meniscal sutures-electively used at our referral center-compared with inside-out techniques.

The purpose of this study is to collect and analyze the cases of patients surgically treated with all-inside sutures for isolated meniscal tears or tears associated with other ligament injuries. The goal is to evaluate the survival and reoperation rates in patients who underwent all-inside meniscal repair for isolated meniscal injuries or those associated with ligament injuries, aged between 12 and 65 years, operated on at the II Clinic of the Rizzoli Orthopaedic Institute between 01/01/2017 and 30/06/2025, with a minimum follow-up of 2 years.

研究设计

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

入排标准

年龄范围
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female patients.
  • Patients who underwent meniscal repair surgery using the all-inside technique for isolated meniscal lesions or lesions associated with ligament injuries between 01/01/2017 and 30/06/2025, with a minimum follow-up of two years.
  • Patients aged between 12 and 65 years at the time of surgery.
  • Patients who have provided consent to participate in the study.
  • Patients who underwent preoperative radiological investigations (MRI) of the affected knee showing meniscal lesions requiring surgical treatment, also confirmed during diagnostic arthroscopy.

排除标准

  • Meniscal lesions resulting from previous meniscal repairs.
  • Patients younger than 12 years or older than 65 years at the time of surgery.
  • Patients who did not provide informed consent.
  • Patients who are no longer contactable.
  • Patients who did not engage in sports activity in the 2 years prior to surgery

结局指标

主要结局

Survival rate

时间窗: 24 months after surgery

Failures and reoperations will be recorded and documented within the CRF, during telephone questionnaires, and through the patient's clinical documentation

次要结局

  • SPORTS (Subjective Patient Outcome for Return To Sports) Score(24 months after surgery)
  • IMPACT activity level score(24 months after surgery)
  • Lysholm Knee Score(24 months after surgery)
  • Tegner Score(24 months after surgery)
  • VAS (Visual Analog Scale)(24 months after surgery)
  • Number of Participants with Radiological Assessment(24 months after surgery)
  • International Knee Documentation Committee (IKDC)(24 months after surgery)
  • KOOS (Knee Injury and Ostearthritis Outcome Score) score(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 (1)

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