A Combined Retrospective and Prospective Protocol to Evaluate Vitoss With and Without Bone Marrow Aspirate for Benign Cavitary Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of Vitoss resorption into the native bone as observed via CT
研究概览
简要总结
This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA). There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in patients identified during the retrospective portion of the study. It is thought that the inclusion of BMA will facilitate the resorption of the graft material, leading to better long-term bone healing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females >/= 18 years of age at the time of surgery
- •Patients treated with Vitoss alone or Vitoss with added BMA between 2004 and 2012
- •willing and able to provide Informed Consent to participate in and follow study requirements (including a radiologic assessment)
排除标准
- •Patients with a known post-traumatic defect
- •active infection at the time of implantation
- •history of bone marrow disorders
- •contraindications to the use of supplemental BMA
结局指标
主要结局
Percentage of Vitoss resorption into the native bone as observed via CT
时间窗: minimum of 24 months post-operatively
Percentage of Vitoss resorption into the native bone will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.
次要结局
- Presence of a rim of radiolucency surrounding the grafted defect as observed by CT(minimum of 24 months post-operatively)
- Bone trabeculation through the defect as observed by CT(minimum of 24 months post-operatively)
- Size of the defect as observed by CT(minimum of 24 months post-operatively)
- Persistence of graft material through the lesion as observed by CT(minimum of 24 months post-operatively)
- Presence of graft within the soft tissue as observed by CT(minimum of 24 months post-operatively)