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临床试验/NCT06376539
NCT06376539已完成不适用

Functional Recovery in the First Six Postoperative Months of Cancer Patients Undergoing Lower Limb Resection and Reconstruction. An Observational Study

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月10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
100
试验地点
1
主要终点
Toronto Extremity Salvage Score (TESS)

研究概览

简要总结

The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.

详细描述

Retrospective observational study will be conducted. The evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. Different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.

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
12 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones.
  • All participants undergone soft tissue resection surgery on the of the lower limb
  • All types of oncological diagnoses will be taken considered: osteosarcoma, Ewing and others.

排除标准

  • Participants who undergo at our Institute only the surgical treatment while continuing adjuvant treatment at other centres
  • Participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our Institute

结局指标

主要结局

Toronto Extremity Salvage Score (TESS)

时间窗: at 6 months after surgery

Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.

Toronto Extremity Salvage Score (TESS)

时间窗: at 3 months after surgery

Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.

次要结局

  • Range of motion (ROM)(at 3 months after surgery)
  • Number of participants able to walk(up to 1 week)
  • Muscle Strength-2(at 6 months after surgery)
  • Rang of motion - 2 (ROM)(at 6 months after surgery)
  • Time Up and Go (TUG)(at 6 months after surgery)
  • Time Up and Go -2 (TUG)(at 3 months after surgery)
  • Muscle Strength(at 3 months after surgery)
  • Number of day from surgery to first walking(up to 1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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