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临床试验/NCT06602414
NCT06602414已完成不适用

Is Conservative Treatment Still an Option for Distal Biceps Tendon Lesions? Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions at 1 Year Minimum Follow-up

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Elbow Function

研究概览

简要总结

A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year.

The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. The results of the affected side will be compared with the controlateral side

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

  • Age greater than or equal to 18 years old at time of injury
  • Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively

排除标准

  • < 18 years at time of injury
  • Patients who present controindications to the strenght evaluation
  • Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries)
  • Patients treated surgically for distal biceps tendon rupture

结局指标

主要结局

Elbow Function

时间窗: At baseline (day 0)

The Mayo Elbow Performance score (MEPS) or Mayo Elbow Performance Index (MEPI) is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL) . This specific test uses 4 subscales: Pain, Range of Motion (arc of motion of the art. humeroulnaris) Stability Daily Function MEPS can be used to measure which treatment work best for different conditions, An example would be when deciding the best post-operative treatment for example: the difference in prognosis between open and closed fractures when operated. This numerical scale express results on a scale from 0 to 100 and considers results with a score higher than 85 as excellent results.

次要结局

  • Upper Limb Function(At baseline (day 0))
  • Short Form Health Survey(At baseline (day 0))
  • Flexion strenght(At baseline (day 0))
  • Flexion Fatigue(At baseline (day 0))
  • Supination Strenght(At baseline (day 0))
  • Supination Fatigue(At baseline (day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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