Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Inclusion Criteria

Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
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
11≤ Adolescents < 20 years old
Patient undergoing treatment of AIS by the MID-C system in daily practice
Subject has no known hypersensitivity and allergies to Titanium
Flexible major curve, correction to below 30° at lateral bending.
Risser sign of 1 to 5
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
Other non-idiopathic scoliosis.
AIS which is not defined as Lenke type 1 or 5
...
Mentally compromised as determined by the physician
Other non-idiopathic scoliosis.
AIS which is not defined as Lenke type 1 or 5
Known active systemic disease, such as AIDS, HIV, or active infection
Cobb angle over 60 degrees
Previous spine surgery.
Known allergy to any component of the device.
Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.

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

Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
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
11≤ Adolescents < 20 years old
Patient undergoing treatment of AIS by the MID-C system in daily practice
Subject has no known hypersensitivity and allergies to Titanium
Flexible major curve, correction to below 30° at lateral bending.
Risser sign of 1 to 5
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
Other non-idiopathic scoliosis.
AIS which is not defined as Lenke type 1 or 5
...
Mentally compromised as determined by the physician
Other non-idiopathic scoliosis.
AIS which is not defined as Lenke type 1 or 5
Known active systemic disease, such as AIDS, HIV, or active infection
Cobb angle over 60 degrees
Previous spine surgery.
Known allergy to any component of the device.
Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.

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