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临床试验/NCT04901559
NCT04901559已完成不适用

Subjective Outcomes After ACL Reconstruction With BQT Autograft

Region Zealand0 个研究点目标入组 30,000 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30,000
主要终点
Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up

研究概览

简要总结

The purpose of the study is to compare short-term patient reported outcome measures (PROM) of Bone-Quadriceps-Tendon (BQT) autograft with Semitendinosus-Gracilis (STG) and Bone-Patellar-Tendon-Bone (BPTB) autografts following Anterior Cruciate Ligament Reconstruction (ACLR).

The PROM used are Knee Injury and Osteoarthrithis Outcome Score (KOOS) and Tegner. Difference in change in KOOS, KOOS subscales and Tegner from preoperative baseline to one-year follow-up and absolute KOOS, KOOS subscales and Tegner at one-year follow-up were evaluated. All of which were BQT compared to STG and BPTB, respectively. The primary outcome is change in KOOS from preoperative baselinge to one-year follow-up. Other outcomes are secondary.

The hypothesis was that patients receiving the BQT autograft show similar results in KOOS, KOOS subscales and Tegner as patients receiving STG or BPTB autografts.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Revision ACL Surgery
  • Multiligament surgery
  • Nonresponders in PROM at preoperative baseline or one-year follow-up

结局指标

主要结局

Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up

时间窗: 1 year

BQT compared to STG and BPTB, respectively

次要结局

  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up(1 year)
  • Change in Tegner activity score from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up(1 year)
  • Absolute results of Tegner activity score at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up(1 year)

研究者

发起方
Region Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesper Glerup

Medical student

Region Zealand

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