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临床试验/NCT05673356
NCT05673356招募中不适用

Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Artromedical Konrad Malinowski Clinic2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年8月28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
25
试验地点
2
主要终点
Knee stability

研究概览

简要总结

Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. Two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; ST or STG) and patellar tendon with two bone blocks (bone - patellar tendon - bone; BPTB). However, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (QT). Multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. Another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, QTB).

The aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (QTB) used in ACLR. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Symptomatic knee anterior and rotatory instability after ACL injury;
  • Primary ACLR cases

排除标准

  • Active inflammation of the knee;
  • Revision cases;
  • Additional PLC, PCL or PFJ injuries (MCL and meniscal lesions are not exclusion criteria);
  • Fractures around the knee

结局指标

主要结局

Knee stability

时间窗: At the 24 month of the follow-up.

Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.

次要结局

  • The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)(At the 24 month of the follow-up.)
  • ROM(At the 24 month of the follow-up.)
  • Retear rate(At the 24 month of the follow-up.)
  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score(At the 24 month of the follow-up.)

研究者

发起方
Artromedical Konrad Malinowski Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Konrad Malinowski MD

Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic

Artromedical Konrad Malinowski Clinic

研究点 (2)

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