|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
H170001 / PAS001 |
| Date Original Protocol Accepted |
10/23/2019
|
| Date Current Protocol Accepted |
09/04/2020
|
| Study Name |
MID-C System Registry PAS
|
| Device Name |
Minimally Invasive Deformity Correction (MID-C) System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
|
| Study Population |
Child: 2-12 yrs, Adolescent: 13-18 yrs, Transitional Adolescent B (as adults): 18-21 yrs. Adolescent patients with adolescent
idiopathic scoliosis (AIS) for treatment of single curves classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of 45 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5-T12.
|
| Sample Size |
Patients implanted with the device in the US within 2 years of FDA’s approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study,with at least 50 patients enrolled by 24 months, 100 patients enrolled by 36 months, and 200 patients enrolled by 48 months. All patients who are implanted with the MID-C System at a participating site in the US will be asked to participate, unless the
patient is seeking treatment at a site where the maximum site enrollment has been reached, until 200 patients are enrolled in the study.
|
| Key Study Endpoints |
Safety Endpoints
Primary: Serious adverse events, and device or procedure related adverse events
Secondary:
1. Rate of adverse events, including by relatedness to device or procedure and severity; and
2. Rate of reoperation, including by type of reoperation.
Probable Benefit Endpoints
Primary: Maintenance of major Cobb angle less than or equal to 40° 5 years post-surgery
Secondary: Annual analysis up to 5 years of the following:
1. Maintenance of major Cobb angle less than or equal to 40°
2. Curve progression no more than 10° of the secondary curve above or below the implant.
3. Composite endpoint analysis (maintenance of major Cobb angle less than or equal to 40° AND freedom from SAEs during MID-C procedure and procedure/device related SAEs following surgery).
4. True failure rate analysis. True failure is defined as conversion to another spinal implant OR major Cobb angle that exceeded 40° at defined follow-up visit OR any curve progression at defined follow-up compared to baseline OR death, OR permanent disability.
|
| Follow-up Visits and Length of Follow-up |
60 months (5 years) of individual post-implantation follow-up
|
