A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scoliosis Correction System, Scoliosis Correction System.
- Who it may be relevant to
- Registry conditions: Idiopathic Scoliosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis
Overview
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
- Device Scoliosis 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. - Device Scoliosis 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 5.0 mm cord diameter was used to treat patients.
Primary outcome measures
- REFLECT Cord Breakage/Separation [Time frame: by latest available time point (minimum 12 months postoperative)]
- Subsequent Surgeries Related to Cord Breakage [Time frame: by latest available time point (minimum 12 months postoperative)]
Secondary outcome measures (3)
- Complications Profile [Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.]
- All Subsequent Surgeries [Time frame: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.]
- Change in Curve [Time frame: From baseline (preoperative) to each postoperative time point.]
Eligibility criteria
Inclusion criteria
Subjects must meet all of the following criteria to be included in the study:
- Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis
- Skeletally immature
- Major Cobb angle of 30° and 65°
- Bone structure adequate to safely accommodate screw fixation
- Failed bracing treatment and/or intolerant to brace wear
- Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve
- 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:
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Prior spinal surgery at the level(s) to be treated
- Known poor bone quality, defined as a T-score of -1.5 or less
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Orthopedic Center — New York
Germany · 1 center
- Eifel Clinic St. Brigida GmbH & Co. KG — Simmerath
Turkey (Türkiye) · 1 center
- Acibadem Maslak Hospital — Istanbul
Identifiers
NCT: NCT07589023 · GMED.REF0325