Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
Recruiting now · Not applicable
Conditions studied: Adolescent Idiopathic Scoliosis
In brief
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.
Key facts
- Study ID
- NCT04441411
- Run by
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- People needed
- 18
- Starts
- 2020-06-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2024-07-30
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- AmsterdamUMC, location AMC — Amsterdam, North Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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