on Fusion Surgery in Adolescent Idiopathic Scoliosis patients
- Conditions
- Adolescent Idiopathic Scoliosis
- Registration Number
- NL-OMON29064
- Lead Sponsor
- not applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Diagnosis of 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* =1 and Skeletal age of hand and wrist X-rays =14y);
-In girls, either pre-menarchal or post-menarchal by no more than 1 year;
-Age over 7 years;
-Non rigid curve;
-All Lenke type;
-No previous spine surgery.
-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 >1;
-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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Efficacy: No progression of the primary curvature, no fusion, no secondary surgery, while enabling growth. Measured by correction of primary curve Cobb angle at 2 years after skeletal maturity, and T1-S1 length, and instrument segment length.<br>2.Safety: Treatment related complications as (Serious) Adverse Event rate, reoperation rate, spine arthrodesis. <br>
- Secondary Outcome Measures
Name Time Method 1.Effectiveness (Radiological assessments)<br>a.T1-S1 length, instrumented segment length, available length for growth; <br>b.Coronal balance (primary and secondary curve Cobb angle);<br>c.Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle);<br>d.Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)<br>e.Vertebral rotation based on PA X-Ray <br>2.Clinical assessments:<br>a.Patient appearance: shoulder imbalance, pelvic imbalance, gibbosity, vertebral rotation (based on scoliometer assesment)<br>b.Patient Reported Outcome (PRO) - SRS-22 (The Scoliosis Research Society’s-22 questionnaire measures multiple domains as pain, self-image, function, and satisfaction with management).<br>