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临床试验/NCT06327217
NCT06327217尚未招募不适用

Long Term Results After Hip Arthroscopy

Reinier Haga Orthopedisch Centrum1 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
451
试验地点
1
主要终点
To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side.

研究概览

简要总结

A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown.

研究设计

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

入排标准

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

入选标准

  • Patient who participated in the cohort study;
  • At least 5 years of follow up;
  • Patient is able to understand the meaning of the study and is willing to sign the Informed Consent Form.
  • A potential subject who meets any of the following criteria will be excluded from participation in this study:

排除标准

  • Patient who has had hip arthroscopy of both sides;
  • Patient is unable or unwilling to sing informed consent

结局指标

主要结局

To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side.

时间窗: 5 to 10 years after hip arthroscopy

To evaluate the degree of osteoarthritis, the Kellgren and Lawrence-scale will be used. The scale ranges from 0 to 4: A score of 0 indicates that there is no evidence of osteoarthritis A score of 4 indicates end-stage OA, marked by severe sclerosis, joint space narrowing (sometimes bone-on-bone contact), and large osteophytes.

次要结局

  • To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy.(5 to 10 years after hip arthroscopy)
  • To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score.(5 to 10 years after hip arthroscopy)
  • To determine patient satisfaction 5-10 years after hip arthroscopy.(5 to 10 years after hip arthroscopy)
  • To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative.(5 to 10 years after hip arthroscopy)
  • To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy.(5 to 10 years after hip arthroscopy)

研究者

发起方
Reinier Haga Orthopedisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (1)

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