Bone Diseases Clinical Trial
— TOCIOfficial title:
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
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Hung AL, Shi B, Chow SK, Chau WW, Hung VW, Wong RM, Liu KL, Lam TP, Ng BK, Cheng JC. Validation Study of the Thumb Ossification Composite Index (TOCI) in Idiopathic Scoliosis: A Stage-to-Stage Correlation with Classic Tanner-Whitehouse and Sanders Simplif — View Citation
Hung ALH, Chau WW, Shi B, Chow SK, Yu FYP, Lam TP, Ng BKW, Qiu Y, Cheng JCY. Thumb Ossification Composite Index (TOCI) for Predicting Peripubertal Skeletal Maturity and Peak Height Velocity in Idiopathic Scoliosis: A Validation Study of Premenarchal Girls — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TOCI stage | Evaluate TOCI stage from 1 to 8 | Baseline, from X-ray scans, higher values represent more mature bone |
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