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