跳至主要内容
临床试验/CTRI/2022/11/047464
CTRI/2022/11/047464尚未招募不适用

Activity limitation and participation restriction in patients treated with proximal humerus nail cement spacer

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Occupational Performance Measure (COPM)

研究概览

简要总结

Lay Summary This study will find the activity limitation and participation restriction experienced by patients following 18 months of Nail Cement Spacer Reconstruction. The long-term aim being designing and implying appropriate rehab for them. Patients will be screened through the medical records for the inclusion exclusion criteria and will be consented for the study. Patients above 18 years of age, treated with nail cement spacer for primary proximal humerus tumor before November 2020 will be assessed one time, on OPD basis in Occupational Therapy department at Tata Memorial Hospital. The study period will be 6-8 months after IEC approval.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria:
  • Patients treated for primary tumors of proximal humerus with wide resection and reconstruction using nail cement spacer with curative intent.
  • Patients treated before November 2020 for primary tumors of proximal humerus nail cement spacer.
  • Age group: >18 years
  • Patients who are able to read, write and communicate in English or Hindi language.

排除标准

  • Exclusion Criteria:
  • Local recurrence /metastasis at the operated site within past 2 years or at the time of evaluation.
  • Current infection at operated site.

结局指标

主要结局

Occupational Performance Measure (COPM)

时间窗: one time assessment

Primary objective:

时间窗: one time assessment

spacer for primary tumours of proximal humerus using Canadian

时间窗: one time assessment

1. To measure Occupational Performance of patients treated with nail cement

时间窗: one time assessment

次要结局

  • Secondary objective:(2. To measure Performance Components using standard Occupational)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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