Thumb Ossification Composite Index (TOCI) to Predict Skeletal Maturity and Curve Progression in AIS

NCT03904914 | Completed DMC

• 1 other identifier: 2016.045
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis; Adolescence; Bone Diseases; Bone Growth Abnormal

Keywords

TOCI; scoliosis

Outcome Measures

Primary Outcomes (1)

• TOCI stage

  Evaluate TOCI stage from 1 to 8

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

Study Arms (1)

AIS group

Patients confirmed with adolescent idiopathic scoliosis (AIS)

Other: TOCI

Interventions

TOCI OTHER

TOCI staging evaluated

AIS group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Scoliosis patients will be recruited from a specialized scoliosis clinic in Prince of Wales hospital visiting the clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (2)

• 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 with Adolescent Idiopathic Scoliosis Followed Longitudinally Until Skeletal Maturity. J Bone Joint Surg Am. 2017 Sep 6;99(17):1438-1446. doi: 10.2106/JBJS.16.01078.

  PMID: 28872525 RESULT

• 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 Simplified Skeletal Maturity Systems. J Bone Joint Surg Am. 2018 Jul 5;100(13):88. doi: 10.2106/JBJS.17.01271.

  PMID: 29975274 RESULT

MeSH Terms

Conditions

Scoliosis; Bone Diseases; Bone Diseases, Developmental

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Musculoskeletal Diseases

Study Officials

• Alec Lik-Hang Hung, Dr.

  Department of Orthopaedics and Traumatology, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: September 1, 2016
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)