A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis
1 other identifier
observational
100
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
Study Completion
Last participant's last visit for all outcomes
July 31, 2027
May 15, 2026
May 1, 2026
8 months
May 5, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (3)
Complications Profile
up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
All Subsequent Surgeries
up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
Change in Curve
From baseline (preoperative) to each postoperative time point.
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
NYU Langone Orthopedic Center
New York, New York, 11554, United States
Eifel Clinic St. Brigida GmbH & Co. KG
Simmerath, Simmerath, 52152, Germany
Acibadem Maslak Hospital
Istanbul, I, 34457, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 15, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share