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Trial record 21 of 970 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Diseases"

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

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ClinicalTrials.gov Identifier: NCT03904914
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Alec Lik-Hang Hung, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment
Scoliosis; Adolescence Bone Diseases Bone Growth Abnormal Other: TOCI

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

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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




Primary Outcome Measures :
  1. TOCI stage [ Time Frame: Baseline, from X-ray scans, higher values represent more mature bone ]
    Evaluate TOCI stage from 1 to 8



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Scoliosis patients will be recruited from a specialized scoliosis clinic in Prince of Wales hospital visiting the clinic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904914


Contacts
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Contact: Alec Lik-Hang Hung, Dr. (852)96712695 alecsprint@gmail.com
Contact: Alec Lik-Hang Hung, Dr. (852)96712695 aleclhhung@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Sha Tin, Hong Kong
Contact: Alec Lik-Hang Hung, Dr.         
Principal Investigator: Alec Lik-Hang Hung, Dr.         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Alec Lik-Hang Hung, Dr. Department of Orthopaedics and Traumatology, Chinese University of Hong Kong

Publications of Results:
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Responsible Party: Dr. Alec Lik-Hang Hung, Associate Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03904914     History of Changes
Other Study ID Numbers: 2016.045
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alec Lik-Hang Hung, Chinese University of Hong Kong:
TOCI
scoliosis
Additional relevant MeSH terms:
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Scoliosis
Bone Diseases
Bone Diseases, Developmental
Spinal Curvatures
Spinal Diseases
Musculoskeletal Diseases