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临床试验/NCT03904914
NCT03904914已完成不适用

Development of a New Simplified Thumb Ossification Composite Index (TOCI) and Its Application to Predict Skeletal Maturity and Curve Progression in Idiopathic Scoliosis and Normal Subjects

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
1
主要终点
TOCI stage

研究概览

简要总结

Accurate skeletal maturity assessment is important for prediction of curve progression and clinical management of adolescent idiopathic scoliosis (AIS) including bracing decision and counseling for prognosis. Determination of the timing of peak growth height velocity and growth remaining are paramount important.1,2 Commonly used clinical or radiological methods are still inadequate or too complex for rapid clinical use in the outpatient setting.3-5 Risser sign had disadvantages of low visibility in posteroanterior (PA) spinal radiograph, wide variability with maturity level and imprecise representation of peak height velocity (PHV) timing.6 Greulich and Pyle atlas (GP atlas) and Tanner-Whitehouse-III (TWIII) method are more reliable and comprehensive classifications to predict maturity, but they are cumbersome and time consuming to be used clinically.7 Both methods require the usage of an atlas, a learning curve required for exact matching of atlas plate or assignment of scores to bones.8

In this study, the investigators introduce Thumb Ossification Classification Index (TOCI). TOCI employed the measurements of epiphysis of distal phalange, proximal phalange, and adductor sesamoid, and results were analyzed together to form a composite stage (composite score) to predict maturity in patient at their peripubertal period. Ultimately the application of TOCI should not be limited to IS patients only. After the establishment of TOCI classification system, the staging system would be applied to radiographs from patients without spinal deformity or suffering from diseases not related to spine.

详细描述

Introduction

Accurate skeletal maturity assessment is important for prediction of curve progression and clinical management of adolescent idiopathic scoliosis (AIS) including bracing decision and counseling for prognosis. Determination of the timing of peak growth height velocity and growth remaining are paramount important.1,2 Commonly used clinical or radiological methods are still inadequate or too complex for rapid clinical use in the outpatient setting.3-5 Risser sign had disadvantages of low visibility in PA spinal radiograph, wide variability with maturity level and imprecise representation of PHV timing.6 Greulich and Pyle atlas (GP atlas) and Tanner-Whitehouse-III (TWIII) method are more reliable and comprehensive classifications to predict maturity, but they are cumbersome and time consuming to be used clinically.7 Both methods require the usage of an atlas, a learning curve required for exact matching of atlas plate or assignment of scores to bones.8

Some latest skeletal maturity bone models were evolved trying to solve these problems but were still imperfect.9 Recently, Sanders made modifications to TWIII method to form Skeletal Maturity Scoring System (SMSS) which focused on epiphysis of small hand bones from all 5 digits. SMSS was proved to have excellent correlation with the curve acceleration phase.10 Digital skeletal age scores between 400 and 425 are associated with the beginning of the curve acceleration phase in adolescent idiopathic scoliosis.11 Excellent intra-observer reliability and substantial inter-observer reliability among senior surgeons were demonstrated in SMSS.12

A new skeletal age classification has yet to be developed, although SMSS has considered a promising method. A recent study to test SMSS's reliability in less experienced staffs demonstrated average inter-observer reliability (K=0.53).8 It showed that a learning curve was present and several recommendations were added in each classification stage to avoid controversy and confusion during usage.13 Therefore, using SMSS requires an organized teaching system with detailed descriptions, self-assessment examinations, viewing presentations and the newly added recommended modification guidelines to improve the reliability. Another scoring system "Distal Radius and Ulna (DRU)" score simplified the measurement to just using radial and ulnar epiphyses but results observed that DRU score had the least correlation of "Radio Ulna and Short bones" (RUS) growth centers with scoliosis behavior.9,10 In addition, the variable appearance of ulnar epiphysis were difficult to be seen clearly.

In this study, the investigators introduce Thumb Ossification Classification Index (TOCI). TOCI employed the measurements of epiphysis of distal phalange, proximal phalange, and adductor sesamoid, and results were analyzed together to form a composite stage (composite score) to predict maturity in patient at their peripubertal period. Ultimately the application of TOCI should not be limited to IS patients only. After the establishment of TOCI classification system, the staging system would be applied to radiographs from patients without spinal deformity or suffering from diseases not related to spine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Male or female
  • Pre-menarche
  • Confirmed diagnosis of idiopathic scoliosis
  • No evidence of neurological abnormality
  • No abnormalities of maturation
  • Risser sign of zero in spinal radiograph and open physis in hand radiograph

排除标准

  • Patients with diagnosis of non-idiopathic scoliosis, e.g. congenital, neuromuscular , syndromal cause of scoliosis
  • Patients with maturation abnormality (either precocious puberty or developmental delay)
  • Abnormalities of the head or neck that would change height measurements
  • Previous history of spinal fusion operation performed

研究组 & 干预措施

AIS group

Patients confirmed with adolescent idiopathic scoliosis (AIS)

干预措施: TOCI (Other)

结局指标

主要结局

TOCI stage

时间窗: Baseline, from X-ray scans, higher values represent more mature bone

Evaluate TOCI stage from 1 to 8

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Alec Lik-Hang Hung

Associate Consultant

Chinese University of Hong Kong

研究点 (1)

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