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临床试验/NCT03442465
NCT03442465招募中不适用

Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone

Memorial Sloan Kettering Cancer Center5 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
5
主要终点
Early recovery level

研究概览

简要总结

The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.

The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery

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

入选标准

  • All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK
  • Current or prior history of primary neoplasms involving osseous structures, including all subtypes
  • Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue/slides
  • Patients must read and understand English
  • Age >/=4
  • Patients must read and understand English

排除标准

  • Patients that weight <17 kilograms

研究组 & 干预措施

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Timed Get Up and Go Test (Behavioral)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Toronto Extremity Salvage Score (Behavioral)

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Orthogonal Radiographs (Diagnostic Test)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Musculoskeletal Tumor Society Score (Behavioral)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Timed Get Up and Go Test (Behavioral)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Orthogonal Radiographs (Diagnostic Test)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Weight Bearing for lower extremities only (Diagnostic Test)

Regenerative Osseous Surgery

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Range of Motion (Diagnostic Test)

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Musculoskeletal Tumor Society Score (Behavioral)

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Toronto Extremity Salvage Score (Behavioral)

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Weight Bearing for lower extremities only (Diagnostic Test)

Other Reconstructive Surgery

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

干预措施: Range of Motion (Diagnostic Test)

结局指标

主要结局

Early recovery level

时间窗: 1 year from surgery

The primary objective is to assess early recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The early time frame is considered at one year from the neoplasm resection surgery.

Mid-recovery level

时间窗: 3 years from surgery

The primary objective is to assess mid-recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The mid-recovery time frame is considered at one year from the neoplasm resection surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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