Idiopathic ScoliosisNCT07589023
A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis, run by Globus Medical Inc at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Scoliosis Correction System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Jun 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Shannon Bahn contact
3 sites in 3 countries
United States1 site
NYU Langone Orthopedic Center
New York, New York, 11554
Korine Pagulayan, 516-324-7500, korine.pagulayan@nyulangone.org
Juan C Rodriguez-Olaverri, MD, PhD
Germany1 site
Eifel Clinic St. Brigida GmbH & Co. KG
Simmerath, Simmerath, 52152
Mahmoud Alkharsawi, MD, +41 02473 89-2325, m.alkharsawi@gmail.com
Per Trobisch, MD
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Istanbul, I, 34457
Tais Zulemyan, +90 212 304 36 36, tais.zulemyan@gmail.com
Ahmet Alanay, MD
About this study
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
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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Scoliosis Correction System
- Keywords
- scoliosis, idiopathic scoliosis, spinal curve, REFLECT System
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis Correction SystemDevice
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.
Scoliosis Correction SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 4.0 Group | 4.0 mm diameter REFLECT cords were used to treat patients. Receives: Device: Scoliosis Correction System | |
| 5.0 Group | 5.0 mm diameter REFLECT cords were used to treat patients. Receives: Device: Scoliosis Correction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
REFLECT Cord Breakage/Separation
Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords
Measured: 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
Measured: by latest available time point (minimum 12 months postoperative)
Secondary outcomes (3)
Complications Profile
Rate of all complications attributable to the REFLECT system
Measured: up to the latest available follow-up visit, with a required minimum of 12 months after surgery.
All Subsequent Surgeries
Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system
Measured: 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)
Measured: From baseline (preoperative) to each postoperative time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589023
- Sponsor's protocol ID
- GMED.REF0325
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07589023
- Acronym / sponsor ID
- GMED.REF0325
- Conditions
- Idiopathic Scoliosis
- Keywords
- scoliosis, idiopathic scoliosis, spinal curve, REFLECT System
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4.0 Group | – | Device: Scoliosis Correction System4.0 mm diameter REFLECT cords were used to treat patients. |
| 5.0 Group | – | Device: Scoliosis Correction System5.0 mm diameter REFLECT cords were used to treat patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoliosis Correction SystemThe 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 | 4.0 Group |
| Scoliosis Correction SystemThe 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. | Device | 5.0 Group |
Primary outcome
REFLECT Cord Breakage/Separation
Time frame: 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
Time frame: by latest available time point (minimum 12 months postoperative)
Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Bahn contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by Globus Medical Inc at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Smith (858-922-7112, rsmith@globusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REFLECT Cord Breakage/Separation (time frame: by latest available time point (minimum 12 months postoperative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.