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Evaluation of the safety and effectiveness of the MID- C system in adolescent idiopathic scoliosis.


- candidate number22461
- NTR NumberNTR5302
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2015
- Secondary IDs2015.223 Institutional Review Board, VU University Medical Center, Amsterdam, The Netherlands
- Public TitleEvaluation of the safety and effectiveness of the MID- C system in adolescent idiopathic scoliosis.
- Scientific TitleSafety and effectiveness evaluation of the Minimal Invasive Deformity Correction (MID-C) System in adolescent idiopathic scoliosis
- ACRONYM
- hypothesisThis study is designed to evaluate the effectiveness and safety of the ApiFix (MID-C) System.
- Healt Condition(s) or Problem(s) studiedAdolescent idiopathic scoliosis (AIS)
- Inclusion criteria1. Adolescent AIS patients (12 years - 17 years old);
2. Standing X-ray: 40 to 55 degrees Cobb angle, Lenke type 1 or 5, Risser stage 1-4;
3. Lateral bending X-ray: primary curve should be reduced to <35 degrees Cobb
angle after lateral bending;
4. Subject has good general health;
5. Subject and both subject‘s guardians/legal representatives are willing to sign a written informed consent form;
6. Vertebral rotation <15 degrees (based on Bunnell Scoliometer), and;
7. Compliance for exercise therapy (based on verbal confirmation of patient)
- Exclusion criteria1. Other non-idiopathic form of scoliosis;
2. Primary curve Cobb angle >55 degrees;
3. AIS which is not defined as Lenke type 1 or 5;
4. Previous spine surgery;
5. Known allergy to titanium;
6. Active systemic disease, such as AIDS, HIV, or active infection;
7. Systemic disease that would affect the subject’s welfare or overall outcome of the study, or;
8. Mentally compromised.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2015
- planned closingdate1-aug-2017
- Target number of participants33
- InterventionsThe spinal deformity of the patients will be surgically corrected using the ApiFix system and sequential correction exercises.
- Primary outcome1. Correction of primary curve Cobb angle at 6 months follow-up (percentage and absolute degrees).
- Secondary outcomeSafety:
1. Curve progression above or below the implant over time at all follow-ups;
2. Vertebral rotation based on Bunnell Scoliometer;
3. Vertebral rotation based on AP X-ray using the Nash and Moe method [7], and;
4. (Serious) adverse event.


Effectiveness:
1. Patient reported outcome (SRS-22);
2. Correction of primary curve Cobb angle to <35 degrees Cobb angle at 6 months follow-up;
3. Correction of primary curve Cobb angle over time at all follow-ups, and;
4. Correction of secondary curve Cobb angle over time at all follow-ups.
- Timepoints2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months postoperatively.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Tsjitske Haanstra
- CONTACT for SCIENTIFIC QUERIES Tsjitske Haanstra
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryThe current gold standard for the treatment of adolescent idiopathic scoliosis is bracing in an early stage. If the curve progresses the scoliosis can be surgically corrected using posterior spinal instrumentation and fusion. Bracing therapy has a large impact on young adolescents resulting in low therapy compliance and the current surgical technique is extensive and irreversible. It is accompanied with risks of neurological damage, wound infection and a major decrease in spinal mobility. The ApiFix system is a novel less invasive short segment pedicle screw based instrumentation. It is connected to the spine around the apex of the main scoliotic curve. The ApiFix system has a ratchet mechanism. By performing specific spinal exercises the ratchet is activated which results in device elongation. This results in a decrease of the scoliotic curvature. Due to the poly-axial joints, correction of the scoliosis is achieved without fusion. This study is designed to evaluate the effectiveness and safety of the ApiFix (MID-C) System. Patients will be recruited in The Netherlands.
- Main changes (audit trail)
- RECORD15-jul-2015 - 18-okt-2015


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