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临床试验/NCT04117334
NCT04117334招募中不适用

Determining the Best Indications for Initiating Brace Treatment for Adolescent Idiopathic Scoliosis

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
2
主要终点
Change in sagittal vertical axis

研究概览

简要总结

This is a prospective study for Investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS). It is hypothesized that aggressive management of adolescent idiopathic scoliosis (AIS) including early bracing at mild curve magnitudes and surgery at 40 degrees is more cost-effective while maintaining similar health quality of life. Scoliosis Research Society 22-item and EuroQol- 5 dimension questionnaires and direct/indirect medical costs will be utilized for the cost-effectiveness analysis and health related quality of life assessment. The findings of this study have the potential to improve decision-making and revolutionize care of AIS patients in Hong Kong and globally. Clinicians will be able to utilize our results to provide the best and most cost-effective timing for initiating brace treatment.

详细描述

Bracing is the mainstay treatment for preventing adolescent idiopathic scoliosis (AIS) progression and the main purpose for treatment is to prevent deformities from reaching the surgical threshold. It has been shown to be effective at reducing curve progression especially in patients with good compliance to treatment. However, bracing should not be used indiscriminately as certain complications have been reported. Bracing too early is safe for curve control but may subject children to prolonged discomfort with the bracing and increased consumption of resources for periodic brace fabrication. Prolonged bracing also reduces spinal mobility, lead to poor body image and self-esteem, and worsen quality of life. Additional risks of osteoporosis and muscular atrophy may also occur. Hence, being able to initiate prompt and appropriate bracing is crucial for achieving optimal curve control and avoiding complications.

Yet, there are still have difficulties identifying patients who may deteriorate. Generally speaking, skeletally immature AIS patients with curves of 20-40 degrees should consider bracing. However, not all of these patients require bracing and some may not need any treatment. More importantly, the resulting curve magnitude on radiographs may not correlate directly with health-related quality of life (HRQOL) measures. As such, the relationship of the Cobb angle prior to initiating brace treatment with long-term HRQOL measures is unknown. The above suggest that there is a significant gap in our knowledge of the optimal timing of brace initiation for managing AIS patients.

In the current setting of rising health-care expenditures, it is also important to assess the "value" of management options and provide the best and cost-effective care for our AIS patients without compromising outcomes or safety. Some clinicians may be more aggressive by bracing children with minor curves while some are content with prescribing braces only when deterioration occurs in moderate curves. In this modern era of healthcare, there is increasing emphasis placed on monitoring and controlling health-care costs to the patient, hospital and insurance companies. Hence, it is an appropriate time to consider the relationship of cost-effectiveness factors and HRQOL measures in designing bracing protocols for AIS patients. With increasing health-care costs, consumption of resources, and the imperative to provide the best healthcare to these children, and focus on a cost-effective delivery of care.

It is thus timely for us to perform this prospective cost-effectiveness comparative study to identify the best indications for initiating brace treatment for AIS patients. Evidence for the best HRQOL outcomes at the lowest cost from both the patient and health-care perspective is necessary to further improve the care for AIS patients. There is potential for the derived model to be applied in other healthcare systems by using a more personalized approach.

For this study, the investigators will utilize mathematical modeling based on factors including initial Cobb angle, maturity status, brace duration, and HRQOL measures to determine the best cost-effective indications for brace treatment. Outcomes will be dependent on the Cobb angle at the end of bracing, HRQOL measures and the overall costs incurred to patients and infrastructure. Our hypothesis is given an AIS patient with significant growth potential, a Cobb angle of 25 degrees is most cost-effective for initiating bracing. On the contrary, bracing for subjects with Cobb angles of 40 degrees or more is not cost-effective regardless of remaining growth.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are diagnosed with adolescent idiopathic scoliosis and are seen in the first setting with remaining growth potential (Risser 0-2), and are prescribed with either underarm (Boston) or Milwaukee bracing

排除标准

  • Patients whose diagnosis is not adolescent idiopathic scoliosis, unable to comply with study follow-up and refused consent for study

结局指标

主要结局

Change in sagittal vertical axis

时间窗: up to 3 years

Change sagittal vertical axis with brace follow-up

Cost-effectiveness of bracing - direct and indirect costs

时间窗: up to 3 years

Costs involve number of clinic follow-up, any form of outpatient and inpatient treatment (including physiotherapy, scoliosis specific exercises, bracing) and complications. Unit cost of investigation, treatment and follow-up. These will be analyzed against the benefits of bracing on clinical parameters, that is, any deterioration of Cobb angle

Change in truncal shift

时间窗: up to 3 years

Changes in truncal shift with brace follow-up

Change in lumbar lordosis

时间窗: up to 3 years

Change in lumbar lordosis with brace follow-up

Change in Cobb angle

时间窗: up to 3 years

Cobb angle changes from final visit as compared to baseline

Change in C7-CSVL

时间窗: up to 3 years

Changes in C7-central sacral vertical line with brace follow-up

Change in thoracic kyphosis

时间窗: up to 3 years

Change in thoracic kyphosis with brace follow-up

Change in rotational profile

时间窗: up to 3 years

Change in 3D parameters/apical rotation with brace follow-up

次要结局

  • Brace compliance(up to 3 years)
  • Patient's quality of life - SRS-22r(up to 3 years)
  • Patient's quality of life - EQ5DY(up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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