DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 908
- 试验地点
- 8
- 主要终点
- Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected
研究概览
简要总结
Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.
详细描述
The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion.
Variables applicable to patients with a degenerative spine disorder which will be collected in the registry include:
- Patient details
- Symptoms
- Diagnosis
- Imaging assessment
- Treatment details
Feasibility phase:
The statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 degenerative spine disorder who receives treatment for the degenerative spine disorder
- •Patient capable of understanding the content of the patient information / Informed Consent Form
- •Patient willing and able to participate in the registry
- •Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki
排除标准
- 未提供
结局指标
主要结局
Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected
时间窗: Every standard of care scheduled follow-up visit up to 3 years
Osteobiologics are classified as autogenous bone graft substitutes, extenders, or enhancers. Types of osteobiologics include demineralized bone matrices (DBM), allografts and allograft formulations, synthetic bone grafts, bone morphogenic proteins, bone marrow aspirate systems, stem cells and platelet-rich plasma systems. The biologics are generally defined as being derived from or replicating natural substances. The osteobiologics are defined as such by possessing one or more of the following properties: osteoinductivity, osteoconductivity, and osteogenicity. Although biologics are classically defined as being derived from or replicating natural substances, a broader definition of an osteobiologic includes synthetic derivatives that may not replicate natural substances, but serve as a bone graft substitute, extender or enhancer. There is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.
次要结局
- Oswestry Disability Index (ODI)(Every standard of care scheduled follow-up visit up to 3 years)
- Distress and Risk Assessment Method (DRAM)(Every standard of care scheduled follow-up visit up to 3 years)
- Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS)(Every standard of care scheduled follow-up visit up to 3 years)
- Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views(12 months after surgery, if this time point is collected as per standard of care)
- Euroqol EQ-5D-3L(Every standard of care scheduled follow-up visit up to 3 years)
- Modified Zung Depression Index(Every standard of care scheduled follow-up visit up to 3 years)
- Scoliosis Research Society (SRS)-22 Questionnaire(Every standard of care scheduled follow-up visit up to 3 years)
- Short Form (SF)-36 V2(Every standard of care scheduled follow-up visit up to 3 years)
- Type of fusion that was performed (posterior and/or anterior/interbody fusion)(12 months after surgery, if this time point is collected as per standard of care)
- Neck Disability Index (NDI)(Every standard of care scheduled follow-up visit up to 3 years)
- Modified Japanese Orthopedic Association Score (mJOA)(Every standard of care scheduled follow-up visit up to 3 years)
- Success of fusion(12 months after surgery, if this time point is collected as per standard of care)
- Type of fusion that was performed (posterior and/or anterior/interbody fusion)(6 months after surgery, if this time point is collected as per standard of care)
- Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views(6 months after surgery, if this time point is collected as per standard of care)
- Success of fusion(6 months after surgery, if this time point is collected as per standard of care)