Surgery for Adolescent Idiopathic Scoliosis without Spinal Fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comfort Tote to help recovery after scoliosis surgery in teens

  This study tests whether a therapeutic Comfort Tote can reduce pain and anxiety after surgery for adolescent idiopathic scoliosis.

  Recruiting Columbia University · New York, New York · NCT07632833

• Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children

  This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.

  Recruiting Phase 3 University of California, San Francisco · San Francisco, California · NCT07561827

• MRI-guided dynamic support for correcting adolescent scoliosis

  This pilot tests whether an MRI-compatible air-padded support with programmable pneumatic control can quickly reduce spinal curvature in 10–16-year-olds with mild to moderate adolescent idiopathic scoliosis.

  Recruiting Chinese University of Hong Kong · Tsim Sha Tsui, Kowloon · NCT07246122

• Detecting scoliosis progression without X-rays using Momentum Spine app

  This study tests whether the Momentum Spine app can reliably detect scoliosis progression in 8-18 year olds without radiographs and guide follow-up care.

  Recruiting Children's Hospital Los Angeles · Los Angeles, California · NCT06825611

• Examining how spinal manipulation affects motor control in adolescents with scoliosis

  This study is testing how spinal manipulation affects movement control in teenagers with scoliosis to see if it helps them improve their balance and muscle function.

  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou · NCT06758115

• Using a 3D camera to assess scoliosis in adolescents

  This study is testing a new way to check the spine of teenagers with scoliosis using a special 3D camera to see if it’s better and safer than traditional X-rays.

  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou, Zhejiang · NCT06717568

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.