Surgery for Adolescent Idiopathic Scoliosis without Spinal Fusion
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System
This study is testing a new type of surgery for teenagers with scoliosis that doesn't involve fusing the spine, to see if it can correct their curvature while still allowing for growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT04441411 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a minimally invasive non-fusion surgical technique using a double rod bipolar posterior spinal implant to correct the spinal curvature in adolescents with progressive idiopathic scoliosis who have not responded to conservative treatments. The approach aims to address the challenges of traditional spinal fusion surgery, which can lead to complications and limit growth. By utilizing the NEMOST system, the study seeks to provide a solution that allows for continued spinal growth while correcting the deformity.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10 and older with idiopathic scoliosis, a primary Cobb angle greater than 30°, and who have experienced curve progression despite non-operative treatment.
Not a fit: Patients with non-idiopathic scoliosis or those who have previously undergone spine surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for adolescents with scoliosis by reducing the need for traditional spinal fusion and its associated complications.
How similar studies have performed: While the approach of non-fusion surgery is gaining interest, this specific technique using the NEMOST system is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescent idiopathic scoliosis ; * Primary Cobb angle greater than 30°; * Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time; * Skeletally immature (Risser grade\* ≤2 and Skeletal age of hand and wrist X-rays ≤14y); * In girl, either pre-menarchal or post-menarchal by no more than 1 year; * Age over 10 years; * Non rigid curve; * All Lenke type; * No previous spine surgery. Exclusion Criteria: * Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis); * History of previous spine surgery; * Risser sign \>2; * Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality); * Non-reductible scoliosis; * Known allergy or intolerance to one of the device material; * Acute or chronic infections, local or systemic; * Absence or insufficience of covering tissues; * Pathological obesity.
Where this trial is running
Amsterdam, North Holland
- AmsterdamUMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: BJ Van Royen, MD, PhD — AmsterdamUMC
- Study coordinator: BJ Van Royen, MD, PhD
- Email: bj.vanroyen@amsterdamumc.nl
- Phone: +31(0)5662672
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.