跳至主要内容
临床试验/NCT05461326
NCT05461326招募中不适用

All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
KT-1000 Arthrometer

研究概览

简要总结

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

详细描述

Patients will be recruited from the PI's population base at Highlands Sports Medicine Clinic. Patients in need of an ACL reconstruction will be asked if they are interested in participating in a study comparing BTB and QT autografts by the PI (Dr. Amit Momaya). The benefits and risks of each graft choice will be thoroughly explained. Both graft options are considered equally appropriate management. Interested patients will be screened for eligibility criteria by a research assistant; those matching eligibility will be consented and enrolled in person at the time of the visit.

Patients will be randomized per trial arm assignment to either (i) assignment "0" or (ii) assignment "1". To ensure randomization, a random number generator is used to assign patient numbers and study groups; these assignments are placed with consent information to remain blinded to research personnel and participants until the consent and enrollment process. We anticipate fifty participants per assignment and oen-hundred participants in total. Assignment 0 represents the BTB group. This procedure harvests the patient's middle third of the patella tendon through a single incision for the new ACL graft. When the graft is in place, the graft is secured using a surgical button at the femoral end and a non-absorbable screw at the tibial end. Assignment 1 represents the QT group. This procedure harvests the patient's quadricep tendon through a single incision then utilizes surgical buttons to fix the graft at the tibial and femoral ends. Following enrollment, patients will immediately be notified of their assignment. Patients will also complete KT-1000 manual maximum side-to-side difference measurements . The patient will then be scheduled for ACL reconstruction surgery according to their assignment.

Following reconstruction, standard of care rehabilitation and mobility instructions will be provided. Participants are expected to complete the usual standard of care 2 week, 6 week, 3 month, 6 month, and 9 month postoperative appointments. At the 2 week and 9 month postoperative visits, a routine x-ray will be performed. Aside from a singular KT-1000 measurement and repeated surveys, the patient should not expect any differences in their postoperative visits compared to if they had not participated in the study.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Skeletally mature patients younger 65
  • ACL insufficiency
  • Scheduled to undergo autograft ACL reconstruction
  • Appropriate candidate for autograft harvest

排除标准

  • <14 or 65>
  • Poor autograft candidate (poor tissue quality)
  • Multi ligamentous reconstruction (PCL, MCL, or PLC)
  • Pregnant or nursing
  • High likelihood of remaining non-compliant with physical therapy regimen
  • Desire to return to sport prior to 6 months
  • Inability to read and write English

研究组 & 干预措施

Quad tendon

Active Comparator

ACL graft harvested from the quadriceps tendon

干预措施: Quad tendon (Procedure)

BTB tendon

Active Comparator

ACL graft harvested from the patellar tendon

干预措施: BTB (Procedure)

结局指标

主要结局

KT-1000 Arthrometer

时间窗: Operative Day, 9 Months Post-Operative Clinic Visit

Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)

次要结局

  • Marx Activity Scale(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)
  • International Knee Documentation Committee (IKDC) Knee Evaluation Form(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)
  • Visual analog scale (VAS)(Post operative day 1, day 2, day 3, week 1, week 2, week 3, week 4, week 6, 3 months, 6 months, 9 months, 12 months, 24 months)
  • ACL Return to Sport Index (ACL-RSI)(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)
  • Short Term Survey (SF-12)(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)
  • Re-rupture rate(2 years)
  • Single Assessment Numeric Evaluation (SANE)(6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Momaya

Associate Professor

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验