Back to resultsPost-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MID-C System
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis
Eligibility Criteria
Inclusion Criteria:
- Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
- Cobb angle between 35-60 degrees (inclusive);
- Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
- Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
- Appropriate candidate for posterior surgical approach;
- Patient has good general health;
- Patient has no known hypersensitivity or allergies to titanium;
- Patient's guardian signs a written informed consent form (ICF).
Exclusion Criteria:
- Any type of non-idiopathic scoliosis;
- Any main thoracic deformity that includes vertebral levels and cranial including to T2;
- Known history of existing malignancy, or any systemic or local infection;
- Spinal cord abnormalities that require treatment;
- Known neurological deficit (defined as motor grade < 5/5);
- Known poor bone quality defined as T score -1.5 or less;
- For female Patient, pregnancy;
- Previous spine surgery that would prevent the successful performance of the MID-C system ;
- Active systemic disease, such as AIDS, HIV, or active infection;
- Active infection or the skin is compromised at the surgical site;
- Systemic disease that would affect the Patient's welfare or overall outcome of the study.
Sites / Locations
- Phoenix Children's HospitalRecruiting
- Rady Children's HospitalRecruiting
- Lucile Packard Children's HospitalRecruiting
- Wolfson children's hospitalRecruiting
- Children's Hospital of Atlanta (CHOA)Recruiting
- Riley Children's HealthRecruiting
- Children's Mercy HospitalRecruiting
- Mayo ClinicRecruiting
- Univ. of Mississippi Medical Center (UMMC)Recruiting
- Women and Children's Hospital - University of Missouri Health CareRecruiting
- Shriners Hospitals for ChildrenRecruiting
- Mount Sinai hospitalRecruiting
- Rainbow babies and childrenRecruiting
- Dayton Children's HospitalRecruiting
- Sanford Univ. of South Dakota Medical CenterRecruiting
- Lebonheur Children's HospitalRecruiting
- University of VirginiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MID-C treatment
Arm Description
Outcomes
Primary Outcome Measures
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04296903
Brief Title
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Official Title
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2020 (Actual)
Primary Completion Date
May 1, 2027 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apifix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MID-C treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MID-C System
Intervention Description
Minimal invasive deformity correction system for the treatment of AIS
Primary Outcome Measure Information:
Title
Maintenance of major Cobb angle ≤ 40° 5 years post-surgery
Description
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
Cobb angle between 35-60 degrees (inclusive);
Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
Appropriate candidate for posterior surgical approach;
Patient has good general health;
Patient has no known hypersensitivity or allergies to titanium;
Patient's guardian signs a written informed consent form (ICF).
Exclusion Criteria:
Any type of non-idiopathic scoliosis;
Any main thoracic deformity that includes vertebral levels and cranial including to T2;
Known history of existing malignancy, or any systemic or local infection;
Spinal cord abnormalities that require treatment;
Known neurological deficit (defined as motor grade < 5/5);
Known poor bone quality defined as T score -1.5 or less;
For female Patient, pregnancy;
Previous spine surgery that would prevent the successful performance of the MID-C system ;
Active systemic disease, such as AIDS, HIV, or active infection;
Active infection or the skin is compromised at the surgical site;
Systemic disease that would affect the Patient's welfare or overall outcome of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphna Zaaroor-Regev, PhD
Phone
+972523763653
Email
Daphna@apifix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Toister
Phone
+972-54-4858102
Email
atoister@orthopediatrics.com
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judson Karlen, MD
Email
jkarlen@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Judson Karlen, MD
First Name & Middle Initial & Last Name & Degree
Dave Bennett, MD
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Newton, MD
Phone
858-966-6789
Email
pnewton@rchsd.org
First Name & Middle Initial & Last Name & Degree
Vidyadhar Upasani, MD
Phone
858-966-6789
Email
vupasani@rchsd.org
First Name & Middle Initial & Last Name & Degree
Peter Newton, MD
First Name & Middle Initial & Last Name & Degree
Burt Yaszay, MD
First Name & Middle Initial & Last Name & Degree
Salil Upasani, MD
Facility Name
Lucile Packard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94304.
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xochitl Bryson
Email
xbryson@stanford.edu
First Name & Middle Initial & Last Name & Degree
Amishi Jobanputra
Email
amishij@stanford.edu
First Name & Middle Initial & Last Name & Degree
Larry Rinsky, MD
First Name & Middle Initial & Last Name & Degree
John Vorhies, MD
First Name & Middle Initial & Last Name & Degree
James Policy, MD
Facility Name
Wolfson children's hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanishia Davis
Email
tanishia.davis@nemours.org
First Name & Middle Initial & Last Name & Degree
Amela Karadzic
Email
amela.karadzic@nemours.org
First Name & Middle Initial & Last Name & Degree
Kevin M Neal, MD
Facility Name
Children's Hospital of Atlanta (CHOA)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Oswald, MD
Phone
404-321-9900
Email
toswald@mypedsortho.com
First Name & Middle Initial & Last Name & Degree
Gilbert Chan, MD
Phone
404-321-9900
Email
gchan@mypedsortho.com
First Name & Middle Initial & Last Name & Degree
Timothy Oswald, MD
First Name & Middle Initial & Last Name & Degree
Gilbert Chan, MD
Facility Name
Riley Children's Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moore Molly
Email
momfreed@iupui.edu
First Name & Middle Initial & Last Name & Degree
Dan Drake, MD
First Name & Middle Initial & Last Name & Degree
Aki Puryear, MD
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Anderson, MD
Email
jtanderson@cmh.edu
First Name & Middle Initial & Last Name & Degree
Richard Schwend, MD
Email
rmschwend@cmh.edu
First Name & Middle Initial & Last Name & Degree
Richard Schwend, MD
First Name & Middle Initial & Last Name & Degree
John Anderson, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle Larson, MD
Phone
507-284-3660
Email
Larson.noelle@mayo.edu
First Name & Middle Initial & Last Name & Degree
Todd Milbrandt, MD
Phone
507-284-3660
Email
Milbrandt.todd@mayo.edu
First Name & Middle Initial & Last Name & Degree
Noelle Larson, MD
First Name & Middle Initial & Last Name & Degree
Todd Milbrandt, MD
Facility Name
Univ. of Mississippi Medical Center (UMMC)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Nehete
Email
pnehete@umc.edu
First Name & Middle Initial & Last Name & Degree
Hamdi Sukkarieh, MD
First Name & Middle Initial & Last Name & Degree
Patrick Wright, MD
Facility Name
Women and Children's Hospital - University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Hoernschemeyer
Email
hoernschemeyerd@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Dan Hoernschemeyer, MD
Facility Name
Shriners Hospitals for Children
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Szymanski, RN, CCRP
Phone
314-432-3600
Ext
1022
Email
dszymanski@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Scott Luhmann, MD
First Name & Middle Initial & Last Name & Degree
Brian Kelly, MD
Facility Name
Mount Sinai hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Wilczek
Email
ashley.wilczek@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Baron Lonner, MD
First Name & Middle Initial & Last Name & Degree
Wesley Bronson, MD
Facility Name
Rainbow babies and children
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Janas Janas
Phone
216-286-8189
Email
michelle.janas@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Michael Glotzbecker, MD
Phone
216-844-8370
Email
Michael.Glotzbecker@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Michael Glotzbecker, MD
First Name & Middle Initial & Last Name & Degree
Christina Hardesty, MD
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C Albert, MD
Phone
937-641-5070
Email
albertm@childrensdayton.org
First Name & Middle Initial & Last Name & Degree
C
First Name & Middle Initial & Last Name & Degree
Michael C Albert, MD
Facility Name
Sanford Univ. of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Haft, MD
Phone
605-328-3944
Email
Geoffrey.haft@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Geoffrey Haft, MD
Facility Name
Lebonheur Children's Hospital
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan K Rowland, BS
Phone
901-287-5413
Email
jrowland@uthsc.edu
First Name & Middle Initial & Last Name & Degree
R
First Name & Middle Initial & Last Name & Degree
Jeff Sawyer, MD
First Name & Middle Initial & Last Name & Degree
William Warner, MD
First Name & Middle Initial & Last Name & Degree
Derek Kelly, MD
First Name & Middle Initial & Last Name & Degree
Ben Sheffer, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy McKnight, MS, ATC
Phone
434-243-0289
Email
HHZ8FZ@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Eric McVey, MEd, CCRP
Phone
434.243.5382
Email
edm9u@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Anuj Singla, M.D
First Name & Middle Initial & Last Name & Degree
Keith Bachman, M.D
12. IPD Sharing Statement
Learn more about this trial
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
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