Study To Evaluate The Continued Safety And Probable Benefit Of The MID-C System For 5 Years Post-Implantation In Adolescent Idiopathic Scoliosis (AIS)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Minneapolis, Minnesota: 20-002525
- Rochester, Minnesota: 20-002525
NCT ID: NCT04296903
About this study
The purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic Scoliosis (AIS).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves.
- Cobb angle between 40-60 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.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Minneapolis, Minn.
Mayo Clinic principal investigator Annalise Larson, M.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator Annalise Larson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available