Using TOCI to predict skeletal maturity and curve progression in scoliosis
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
Chinese University of Hong Kong · NCT03904914
This study is testing if a new method using hand bone growth can help doctors predict how scoliosis will progress in young teens with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Sha Tin) |
| Trial ID | NCT03904914 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the Thumb Ossification Composite Index (TOCI) as a method for predicting skeletal maturity and curve progression in adolescents with idiopathic scoliosis. The study addresses the limitations of existing skeletal maturity assessment methods, which are often too complex or inadequate for quick clinical use. By focusing on the ossification of small hand bones, the TOCI seeks to provide a more reliable and efficient way to assess growth and inform treatment decisions, such as bracing and prognosis counseling. Participants will be pre-menarche adolescents diagnosed with idiopathic scoliosis and will undergo radiographic assessments to determine their skeletal maturity.
Who should consider this trial
Good fit: Ideal candidates for this study are pre-menarche adolescents diagnosed with idiopathic scoliosis who meet specific radiographic criteria.
Not a fit: Patients with non-idiopathic scoliosis or those with maturation abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely assessments of skeletal maturity, improving management and outcomes for adolescents with scoliosis.
How similar studies have performed: While there have been advancements in skeletal maturity assessment methods, the TOCI approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sha Tin
- Prince of Wales Hospital — Sha Tin, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Alec Lik-Hang Hung, Dr. — Department of Orthopaedics and Traumatology, Chinese University of Hong Kong
- Study coordinator: Alec Lik-Hang Hung, Dr.
- Email: alecsprint@gmail.com
- Phone: (852)96712695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scoliosis, Adolescence, Bone Diseases, Bone Growth Abnormal, TOCI, scoliosis