No registrations found.
ID
Source
Health condition
Surgical treatment of adolescent idiopathic scoliosis (AIS).
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Correction of primary curve Cobb angle at 6 months follow-up (percentage and absolute degrees).
Secondary outcome
Safety:
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.
Background summary
The 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.
Study objective
This study is designed to evaluate the effectiveness and safety of the ApiFix (MID-C) System.
Study design
2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months postoperatively.
Intervention
The spinal deformity of the patients will be surgically corrected using the ApiFix system and sequential correction exercises.
Tsjitske Haanstra
De Boelelaan 1117
Amsterdam 1081 HC
The Netherlands
+31(0)20-4445028
t.haanstra@vumc.nl
Tsjitske Haanstra
De Boelelaan 1117
Amsterdam 1081 HC
The Netherlands
+31(0)20-4445028
t.haanstra@vumc.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5162 |
| NTR-old | NTR5302 |
| Other | Institutional Review Board, VU University Medical Center, Amsterdam, The Netherlands : 2015.223 |