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

February 6, 2023 updated by: Dr. Alec Lik-Hang Hung, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AIS group
Patients confirmed with adolescent idiopathic scoliosis (AIS)
Other: TOCI
TOCI staging evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOCI stage
Time Frame: Baseline, from X-ray scans, higher values represent more mature bone
Evaluate TOCI stage from 1 to 8
Baseline, from X-ray scans, higher values represent more mature bone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016.045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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