跳至主要内容
临床试验/NCT01829633
NCT01829633已完成不适用

Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears

Martina Hansen's Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Shoulder sonography

研究概览

简要总结

Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005.

Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are

  • the number of relapses during follow-up,
  • the need for surgical treatment during follow-up,
  • the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up
  • the actual clinical shoulder condition (as given by shoulder scores) at reexamination.

Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.

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

入选标准

  • Full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and MRI.
  • At the time of diagnosis (2002 to 2005):
  • Typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (Neer or Hawkins)
  • Potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to Thomazeau, fatty degeneration not exceeding grade 1 according to Goutallier).
  • Treated by physiotherapy for at least 3 months

排除标准

  • At the time of diagnosis (2002 to 2005):
  • Full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons
  • Other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis
  • Earlier treated with rotator cuff repair in the study shoulder

结局指标

主要结局

Shoulder sonography

时间窗: Baseline to 8-10 years follow-up

Sonographic shoulder examination was performed for all study patients before treatment was given. All patients will be reexamined by sonography after 8 to 10 years. The finding of interest is the change of tear size as determined by sonography

次要结局

  • Number of patients who needed surgical treatment of their shoulder during follow-up(8 to 10 years)
  • MRI of the shoulder(MRI will be performed at 8 to 10 years follow-up)
  • Number of relapses during follow-up(8 to 10 years)

研究者

发起方
Martina Hansen's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Moosmayer

MD, PhD

Martina Hansen's Hospital

研究点 (1)

Loading locations...

相似试验