N/A
N=20
Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis
Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT03194568 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Sep 2024
Primary outcome: Primary: Incidence of Treatment-Emergent Adverse Events — 11; 7; 20; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anterior Vertebral Tether (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Patrick Cahill, MD
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
11; 7; 20; 0 | — |
| SECONDARY Comparison of Pre-Operative and Post-Operative Cobb Angle |
14; 6 | — |
| SECONDARY Comparison of Pre-Operative and Post-Operative SRS 30 Scores |
4.4; 4.3; 3.6; 4.2; 3.5; 4.1 | — |
Summary
This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of anterior approach surgery for spinal deformity in pediatric idiopathic scoliosis.
Eligibility Criteria
Inclusion Criteria
- Males or females age 8 to 16 years old at time of enrollment (inclusive)
- Diagnosis of idiopathic scoliosis
- Sanders bone age of less than or equal to 4
- Thoracic curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
- Lumbar curve less than 35 degrees
- Patient has already been identified for and recommended to have surgical intervention
- Spina bifida occulta is permitted
- Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the subject has not had any previous surgery for this, and no surgery is planned in the future
Exclusion Criteria
- Pregnancy (current)
- Prior spinal or chest surgery
- MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- Associated syndrome, including Marfan syndrome or neurofibromatosis
- Sanders bone age greater than 4
- Thoracic curve less than 35 degrees or greater than 60 degrees
- Lumbar curve greater than or equal to 35 degrees
- Unable or unwilling to firmly commit to returning for required follow-up visits
- Investigator judgement that the subject/family may not be a candidate for the intervention
Data sourced from ClinicalTrials.gov (NCT03194568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.