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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2018年2月14日

概览

阶段
不适用
干预措施
Timed Get Up and Go Test
疾病 / 适应症
Bone Sarcoma
发起方
Memorial Sloan Kettering Cancer Center
入组人数
300
试验地点
5
主要终点
Early recovery level
状态
招募中
最后更新
15天前

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

注册库
clinicaltrials.gov
开始日期
2018年2月14日
结束日期
2027年2月14日
最后更新
15天前
研究类型
Observational
性别
All

研究者

入排标准

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

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

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

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

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

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

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

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

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

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

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

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

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.

研究点 (5)

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