3D, Dynamic and Mechanically-informed Decision Making in AIS
Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic pro
| Condition(s) | Adolescent Idiopathic Scoliosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, |
| Who can participate | Inclusion Criteria: * Patient diagnosed with Adolescent Idiopathic Scoliosis * 10-35 years old * Patient is scheduled to be surgically treated by vertebral body tethering (VBT) or selective fusion at UZ Leuven * Informed consent obtained: also from parent/guardian in case of minors Exclusion Criteria: * Patient has undergone a fusion or VBT procedure before * Patient has a severe underlying illness which might influence the outcome of the surgery * Making it reasonable for the investigator to exclude the patient |
| Ages | 10 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Leuven, Vlaams-Brabant, Belgium |
| Start date | 2021-01-19 |
| NCT ID | NCT04761549 |
| Official listing | https://clinicaltrials.gov/study/NCT04761549 |