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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4.0 Group | 4.0 mm diameter REFLECT cords were used to treat patients. |
| |
| 5.0 Group | 5.0 mm diameter REFLECT cords were used to treat patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoliosis Correction System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| REFLECT Cord Breakage/Separation | Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords | by latest available time point (minimum 12 months postoperative) |
| Subsequent Surgeries Related to Cord Breakage | Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation | by latest available time point (minimum 12 months postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications Profile | Rate of all complications attributable to the REFLECT system | up to the latest available follow-up visit, with a required minimum of 12 months after surgery. |
| All Subsequent Surgeries |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
Exclusion Criteria:
Patients were excluded from the study if they met any of the following conditions:
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The study population consists of skeletally immature pediatric and adolescent patients with progressive idiopathic scoliosis who were treated surgically with the REFLECT™ Scoliosis Correction System as part of routine clinical care. Eligible patients had a major spinal curve between 30° and 65°, required surgical correction after failing or being unable to tolerate bracing, and had adequate bone quality to support screw fixation.
This is a multicenter, international retrospective cohort including approximately 100 patients treated at participating institutions in Germany, Turkey, and the United States. The cohort includes patients treated with either 4.0 mm or 5.0 mm REFLECT cords, using single or dual cords per curve, with at least 12 months of postoperative clinical and radiographic follow-up available for review.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Smith | Contact | 858-922-7112 | rsmith@globusmedical.com | |
| Shannon Bahn | Contact | sbahn@globusmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Orthopedic Center | New York | New York | 11554 | United States |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Scoliosis Correction System | Device | 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 5.0 mm cord diameter was used to treat patients. |
|
Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system
| up to the latest available follow-up visit, with a required minimum of 12 months after surgery. |
| Change in Curve | Change in curve(s), as measured by the change in Cobb angle(s) | From baseline (preoperative) to each postoperative time point. |
| Eifel Clinic St. Brigida GmbH & Co. KG | Simmerath | Simmerath | 52152 | Germany |
|
| Acibadem Maslak Hospital | Istanbul | I | 34457 | Turkey (Türkiye) |
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