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临床试验/NCT04039971
NCT04039971进行中(未招募)不适用

Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
2
主要终点
Short-Term Graft Superiority

研究概览

简要总结

In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

详细描述

It is well known that ACL injuries are among the most common sports and knee injuries. As a result, ACL reconstruction is at the forefront both in terms of research and development and advancements in technique. One focus of research is graft choice and the risks and benefits associated with each. There are multiple valid graft choices including bone-patellar tendon-bone, hamstring tendon, quadriceps tendon, quadriceps tendon-patellar bone, and allograft. Graft choice is often patient centered and based on both patient and surgeon considerations such as age, sex, activity level, surgeon preference and graft associated complications.

The present study seeks to compare the intraoperative, immediate perioperative, intermediate and long-term outcomes between tendon-bone and all-soft-tissue quadriceps tendon autograft in ACL reconstruction in adolescent patients. The investigators will analyze data on operative time, cost, complications, recovery of strength and range of motion, return to sports rates, patient reported outcomes, and failure rates. With this proposal the investigators hope to determine if there is a superior graft technique in this population. Both graft types are validated in the literature separately as options for ACL reconstruction in this age group. There has been no clinical research comparing the two graft types, and therefore no consensus is made among surgeons on whether to use tendon-bone or all-soft-tissue when it comes to the QT autograft. A secondary aim of this study is to obtain patient reported outcomes throughout the post-operative period to determine if the patient experience is different between the two graft types. This data may be used in guiding a surgeon's decision on which type to use with their patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • Patients ages 12 to 19 (inclusive)
  • Patients undergoing primary ACL reconstruction

排除标准

  • Patients with an underlying neuromuscular diagnosis or neurological injury
  • Patients with lower extremity fractures, dislocations, or multi-ligamentous injuries, which required surgery, concurrent with or occurring two years or less prior to primary ACL injury.
  • Patients with an underlying systemic or musculoskeletal diagnosis

研究组 & 干预措施

Tendon-Bone Graft

Active Comparator

Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.

干预措施: ACL Reconstruction (Procedure)

All-Soft-Tissue Graft

Active Comparator

Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

干预措施: ACL Reconstruction (Procedure)

结局指标

主要结局

Short-Term Graft Superiority

时间窗: 1 to 2 years

Graft superiority will be evaluated by the time to return to sports and the length of return to sports.

Long-Term Graft Superiority

时间窗: 5 years

Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.

次要结局

  • Patient Reported Outcomes(Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments)
  • Time to Return to Sports Rates(As recorded in post-operative physical therapy visits (approx. 6 months to 1 year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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