Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jun 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of surgery for adolescents with a condition called adolescent idiopathic scoliosis (AIS), which causes an abnormal curve in the spine. The surgery uses a special device called a non-fusion double rod bipolar posterior spinal implant, designed to correct the curvature without permanently fusing the spine. This trial is looking for patients who are between 10 and 21 years old, have a significant spinal curve (greater than 30 degrees), and have not seen improvement from other treatments. Eligible participants must also be growing, as determined by specific skeletal maturity criteria.

If you or your child join this trial, you can expect to undergo this minimally invasive surgery, which aims to improve the spinal curve and help with any related symptoms. The study is currently recruiting participants, and it’s important to note that there are specific criteria for eligibility to ensure safety and effectiveness. Participants will be closely monitored throughout the trial to assess how well the treatment works. This could be a promising option for those struggling with AIS after other treatments have not been successful.

Gender

ALL

Eligibility 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.