Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
AmsterdamUMC, location AMC
RECRUITING
Amsterdam
Contact Information
Primary
BJ Van Royen, MD, PhD
bj.vanroyen@amsterdamumc.nl
+31(0)5662672
Backup
AMC AmsterdamUMC
amcfoundation@amc.nl
+31(0)205669111
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 18
Treatments
Other: NEMOST-AIS
This study is designed as a cohort study.
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)