Status:
TERMINATED
Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)
Lead Sponsor:
Apifix
Conditions:
Adolescent Idiopathic Scoliosis (AIS)
Eligibility:
All Genders
11-20 years
Brief Summary
Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the vertebrae and discs gradually develop a curvature that is first detected in patients between 11 and 20 years...
Detailed Description
The study is designed as a European, observational study with a 12-month follow-up period. Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will be included durin...
Eligibility Criteria
Inclusion
- 11≤ Adolescents \< 20 years old
- Patient undergoing treatment of AIS by the MID-C system in daily practice
- Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
- Flexible major curve, correction to below 30° at lateral bending.
- Risser sign of 1 to 5
- Appropriate candidate for posterior surgical approach as determined by surgeon
- Subject has good general health as determined by physician.
- Subject has no known hypersensitivity and allergies to Titanium
- Subject's guardian willing to sign a written Informed Consent Form (ICF)
Exclusion
- Cobb angle over 60 degrees
- Other non-idiopathic scoliosis.
- AIS which is not defined as Lenke type 1 or 5
- Previous spine surgery.
- Known allergy to any component of the device.
- Known active systemic disease, such as AIDS, HIV, or active infection
- Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.
- Mentally compromised as determined by the physician
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02200302
Start Date
October 1 2014
End Date
May 1 2016
Last Update
March 9 2017
Active Locations (1)
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1
Unité d'Orthopédie-traumatologie, Rachis II
Bordeaux, France