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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2024年4月10日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Bone Neoplasm
发起方
Istituto Ortopedico Rizzoli
入组人数
100
试验地点
1
主要终点
Toronto Extremity Salvage Score (TESS)
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年4月10日
结束日期
2026年1月31日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

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