Multicenter Prospective Registry to Evaluate Use and Outcomes of Burst Biologics Products in Foot and Ankle Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Fusion (%) Number of fusion patients fused/all fusion patients operated
研究概览
简要总结
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as determining relevant patient outcomes.
详细描述
Foot and ankle surgery requiring the use of bone graft is common despite recent advancements and improved outcomes with new motion preservation devices (ankle replacement). Autogenous bone remains the gold standard but is complicated by donor site morbidity and availability of a sufficient volume of graft. Over the past two decades surgeon interest in alternative bone grafts has steadily increased. Bone morphogenic proteins, synthetic bone graft substitutes, and various allograft products are widely available to surgeons. Limitations on the use of allografts in the past were mainly attributed to less than optimal donor screening and processing techniques which removed viable components needed to aid in the bone healing process.
In recent years, the focus and scientific advances in various allograft processing techniques have allowed the retention of various viable cytokines, growth factors, and cell populations which result in enhanced osteogenic and osteoinductive properties. Rigorous donor bone screening and meticulous testing has virtually eliminated the risk of disease transmission.
A unique proprietary cryoprotection processing technique for allograft tissue was developed by Smart-Surgical, Inc. and a complete line of allograft products was created and is now marketed by Burst Biologics (dba). In addition, rigorous standardized laboratory assay techniques and statistical analysis provide consistency and uniformity of the biologically active components of Burst allograft products.
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as determining relevant patient outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older
- •Patient diagnosed with a pathology of the hindfoot, foot, or ankle requiring surgical intervention.
- •The surgeon has determined that a Burst Biologic product is or was clinically indicated.
- •Patient capable of understanding the content of the Informed Consent Form.
- •Patient willing and able to participate in the registry protocol including the surgeon's standard follow-up visits and clinical evaluations.
- •Patient who has agreed to participate in the registry by providing consent per the applicable local law and the declaration of Helsinki.
排除标准
- •The following are relative contraindications for the use of Burst Products, however the investigator surgeon is solely responsible for the determination of patient eligibility for surgery:
- •Severe vascular or neurological disease
- •Uncontrolled diabetes
- •Severe degenerative disease (other than degenerative disc disease)
- •Hypercalcemia, abnormal calcium metabolism
- •Existing acute or chronic infections, especially at the site of the operation
- •Inflammatory bone disease such as osteomyelitis
- •Malignant tumors
- •Patients who are or plan to become pregnant.
结局指标
主要结局
Fusion (%) Number of fusion patients fused/all fusion patients operated
时间窗: 6 Months
Determined by CT Scan or Plain Radiographs
Bone Consolidation (%) Number of osteotomy patients with bone consolidation/all osteotomy patients operated
时间窗: 6 Months
Determined by CT Scan or Plain Radiographs
次要结局
- Visual Analog Scale (VAS)(6 Months)
- Change from Baseline in American Orthopedic Foot and Ankle Society Questionnaire (AOFAS) Score(6 Months)
- Change from Baseline in Foot Function Index Score (FFI)(6 Months)
- Change from Baseline in Short Form-36 V2(6 Months)
研究者
Burst Biologics
Medical Affairs Officer
Smart-Surgical Inc. dba Burst Biologics