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临床试验/NCT04057651
NCT04057651已完成不适用

Study of Self-assessment Questionnaires Used in Hip and Knee Surgery

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年8月28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
800
试验地点
1
主要终点
Oxford Hip Score

研究概览

简要总结

Patient-reported outcome measures (PROMs) are currently used for evaluating orthopaedic procedures. Nevertheless, there is no consensus in the different studies, making them difficult to compare . The score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score.

Moreover , Minimal clinically important differences (MCID) is the smallest change in a treatment outcome that a patient would identify as important. The MCID is also not clearly identified for the French population for the hip and knee orthopaedic scores.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hip osteoarthritis (certified by standard radiographs)
  • Knee osteoarthritis ( certified by standard radiographs)

排除标准

  • Systemic inflammatory disease
  • Surgery revision

结局指标

主要结局

Oxford Hip Score

时间窗: The day Before surgery

t is a 12-item patient-reported outcome measure designed to assess disability after surgery to the hip. Each item was scored between 0 and 4, with 4 been the best outcome per question producing overall scores running from 0 to 48(48 being the best outcome); \> 41 is excellent, 34 - 41 is good,27 -33 as fair, and \<27 is poor.

KOOS score

时间窗: The day Before surgery

Knee injury and Osteoarthritis Outcome Score (KOSS)

HOOS Score

时间窗: The day Before surgery

The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.

Oxford knee score

时间窗: The day Before surgery

Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.

次要结局

  • KOOS score(an average between 6 to 9 months after surgery)
  • Oxford Hip Score(an average between 6 to 9 months after surgery)
  • HOOS Score(an average between 6 to 9 months after surgery)
  • Oxford knee Score(an average between 6 to 9 months after surgery)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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