AzTrials
AzTrials

Scoliosis; AdolescenceTOCINCT03904914

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

An observational study of Scoliosis; Adolescence and Bone Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
TOCI
How many people
1,500 participants
Where
1 siteHong Kong
Study dates
1 Sep 2016to 3 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

Official 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.

Read the detailed description

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.

The objectives of this study were as follows:

  1. Measure different bony features at hand bones and classify the bony features to TOCI stages
  2. Evaluate the TOCI system by comparing the measured TOCI stages with digital skeletal age (DSA) and radio ulna and short bones (RUS) scores
  3. Evaluate the intra-rater and inter-rater reliability of TOCI system
Being tested
TOCI
Keywords
TOCI, scoliosis
Medical subject headings
Scoliosis, Bone Diseases, Bone Diseases, Developmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOCIOther

    TOCI staging evaluated

Study groups in NCT03904914
Study groupRoleWhat they receive
AIS groupPatients confirmed with adolescent idiopathic scoliosis (AIS)
Receives: Other: TOCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TOCI stage

    Evaluate TOCI stage from 1 to 8

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start1 Sep 2016
  3. Primary completion3 Mar 2026
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904914
Sponsor's protocol ID
2016.045
Acronym
TOCI
Status last verified
Mar 2026
First submitted
2 Apr 2019
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28872525
  • 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.

    PubMed 29975274

Questions about this trial

What is this clinical trial studying?

An observational study of Scoliosis; Adolescence and Bone Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TOCI stage (time frame: Baseline, from X-ray scans, higher values represent more mature bone). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03904914, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in