NCT01880164已完成不适用
Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated With Low Grade Scoliosis: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility
Shay Bess10 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.
详细描述
- Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis.
- Identify disease burden of specific demographic and radiographic features associated with ASD.
- Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.
- Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities.
- Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension.
- Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up.
- Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD.
- Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75 years of age at the time of enrollment.
- •Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique
- •Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees
排除标准
- •Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring <10 degrees or >40 degrees
- •Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)
- •Cardiopulmonary disease or comorbidities that preclude surgical intervention
- •Patient not deemed surgical candidate by treating surgeon
- •Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Initial visit and six months post enrollment
This questionnaire has been designed to provide information as to how back pain affects ability to manage in everyday life. Score must be equal to or greater than 30 for eligibility to enroll.
次要结局
- Radiographs(Initial visit (Day 1))
研究者
Shay Bess
President, ISSGF
International Spine Study Group Foundation
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Evaluation of Effect of Non-surgical Spinal Decompression Therapy in Lumbosacral Disc HerniatioDiseases of the musculo-skeletal system and connective tissueKCT0002614Seoul National University Bundang Hospital50
已完成
不适用
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)Dysfunction of the Prosthetic ConductLesions of the Right Ventricular Outflow TractNCT01250327Assistance Publique - Hôpitaux de Paris93
已完成
不适用
Cervical Spondylotic Myelopathy - Cost Observational Surgical TrialCervical Spondylosis With MyelopathyNCT05994404Lahey Clinic269
进行中（未招募）
不适用
Non-surgical Spinal Decompression Therapy and OutcomesLow Back PainHerniation, DiscSciatic RadiculopathyIntervertebral Disc Stenosis of Neural CanalIntervertebral Disc InjuryNCT06525896University of South Florida42
已完成
不适用
Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)Lumbar Spinal StenosisNCT01943435Michael Schneider, DC, PhD259