Status:
RECRUITING
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief 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 i...
Detailed Description
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is unknown. Children wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04441411
Start Date
June 1 2020
End Date
December 31 2028
Last Update
July 30 2024
Active Locations (1)
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1
AmsterdamUMC, location AMC
Amsterdam, North Holland, Netherlands, 1105AZ