Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Inclusion Criteria

Risser sign of 1 to 5
Flexible major curve, correction to below 30° at lateral bending.
11≤ Adolescents < 20 years old
...
Risser sign of 1 to 5
Flexible major curve, correction to below 30° at lateral bending.
11≤ Adolescents < 20 years old
Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
Subject has no known hypersensitivity and allergies to Titanium
Patient undergoing treatment of AIS by the MID-C system in daily practice
Subject has good general health as determined by physician.
Appropriate candidate for posterior surgical approach as determined by surgeon
Subject's guardian willing to sign a written Informed Consent Form (ICF)

Exclusion Criteria

Mentally compromised as determined by the physician
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
...
Mentally compromised as determined by the physician
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.
Cobb angle over 60 degrees
Other non-idiopathic scoliosis.
Known active systemic disease, such as AIDS, HIV, or active infection
Known allergy to any component of the device.

Summary

Conditions
Adolescent Idiopathic Scoliosis (AIS)
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 11 years and 20 years
Gender
Both males and females

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 during a 6-month enrollment period.

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 during a 6-month enrollment period.

Inclusion Criteria

Risser sign of 1 to 5
Flexible major curve, correction to below 30° at lateral bending.
11≤ Adolescents < 20 years old
...
Risser sign of 1 to 5
Flexible major curve, correction to below 30° at lateral bending.
11≤ Adolescents < 20 years old
Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
Subject has no known hypersensitivity and allergies to Titanium
Patient undergoing treatment of AIS by the MID-C system in daily practice
Subject has good general health as determined by physician.
Appropriate candidate for posterior surgical approach as determined by surgeon
Subject's guardian willing to sign a written Informed Consent Form (ICF)

Exclusion Criteria

Mentally compromised as determined by the physician
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
...
Mentally compromised as determined by the physician
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.
Cobb angle over 60 degrees
Other non-idiopathic scoliosis.
Known active systemic disease, such as AIDS, HIV, or active infection
Known allergy to any component of the device.

Tracking Information

NCT #
NCT02200302
Collaborators
Not Provided
Investigators
  • Principal Investigator: JEAN-CHARLES LE HUEC, PD Dr. med. Unité d'Orthopédie-traumatologie, Rachis II
  • JEAN-CHARLES LE HUEC, PD Dr. med. Unité d'Orthopédie-traumatologie, Rachis II
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