Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Inclusion Criterias

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

Exclusion Criterias

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
...
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
Known allergy to any component of the device.
Cobb angle over 60 degrees
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
Other non-idiopathic scoliosis.

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 Criterias

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

Exclusion Criterias

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
...
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
Known allergy to any component of the device.
Cobb angle over 60 degrees
AIS which is not defined as Lenke type 1 or 5
Previous spine surgery.
Other non-idiopathic scoliosis.

Locations

Bordeaux
Bordeaux

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