跳至主要内容
临床试验/NCT03182647
NCT03182647Unknown不适用

Long-term Follow-up of Anterior Cruciate Ligament Injury

Linkoeping University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年6月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Self reported knee function

研究概览

简要总结

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. This can help to explain why so much of orthopaedic research is devoted to evaluating the outcomes of ACL injury. However, while there has been extensive study of short-term (up to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after their ACL injury. This is important because long-term follow-up can provide key insights to guide the information provided to newly injured patients (e.g. to help set realistic expectations of what the injured person can expect of their knee function in the future), and help us evaluate the efficacy of previous treatments.

The primary aim is to assess the influence of an acute ACL injury on knee function and quality of life, 32-37 years after the index injury. Approximately 300 patients injured between 1980 and 1985 will be invited to participate in the study. Patient- and clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.

详细描述

Patients injuring their ACL between 1980 and 1985 have periodically been followed since the injury. Now, we plan to contact all patients and invite them to participate. The patients will be asked to

  1. complete a questionnaire battery
  2. visit the movement laboratory at Linköping University for an objective assessment of knee function and
  3. have an x-ray of both knee joints.

Baseline information including associated injuries, treatment and activity level exist for all the patients. At that time, rehabilitation was normally completed after 4-6 months for non-operatively treated patients, and nine months after ACL surgery.

研究设计

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

入排标准

年龄范围
47 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary ACL injury between 1980 and 1985, age between 15 and 40 at injury

排除标准

  • all patients from the initial cohort will be invited for participation

结局指标

主要结局

Self reported knee function

时间窗: 32-37 years after ACL injury

Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)

Osteoarthritis

时间窗: 32-37 years after ACL injury

Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs

次要结局

  • Quality of life(32-37 years after ACL injury)
  • Physical activity(32-37 years after ACL injury)
  • Objective assessment of knee function(32-37 years after ACL injury)
  • Associated injuries and additional surgery(32-37 years after ACL injury)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Joanna Kvist

Professor

Linkoeping University

研究点 (1)

Loading locations...

相似试验