Idiopathic Scoliosis
Conditions
Keywords
scoliosis, idiopathic scoliosis, spinal curve, REFLECT System
Brief summary
This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.
Interventions
DEVICEScoliosis Correction System
The REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 4.0 mm cord diameter was used to treat patients.
Sponsors
Globus Medical Inc
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be included in the study: 1. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis 2. Skeletally immature 3. Major Cobb angle of 30° and 65° 4. Bone structure adequate to safely accommodate screw fixation 5. Failed bracing treatment and/or intolerant to brace wear 6. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve 7. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative
Exclusion criteria
Patients were excluded from the study if they met any of the following conditions: 1. Presence of any systemic infection, local infection, or skin compromise at the surgical site 2. Prior spinal surgery at the level(s) to be treated 3. Known poor bone quality, defined as a T-score of -1.5 or less 4. Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REFLECT Cord Breakage/Separation | by latest available time point (minimum 12 months postoperative) | Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords |
| Subsequent Surgeries Related to Cord Breakage | by latest available time point (minimum 12 months postoperative) | Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications Profile | up to the latest available follow-up visit, with a required minimum of 12 months after surgery. | Rate of all complications attributable to the REFLECT system |
| All Subsequent Surgeries | up to the latest available follow-up visit, with a required minimum of 12 months after surgery. | Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system |
| Change in Curve | From baseline (preoperative) to each postoperative time point. | Change in curve(s), as measured by the change in Cobb angle(s) |
Countries
Germany, Turkey (Türkiye), United States
Contacts
CONTACTRebecca Smith
CONTACTShannon Bahn
Outcome results
None listed