Idiopathic ScoliosisNCT06298812
REFLECT Scoliosis System Post Approval Study
A study testing REFLECT Scoliosis Correction System in people with Idiopathic Scoliosis, run by Globus Medical Inc at 2 sites in United States.
Trial summary
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- REFLECT Scoliosis Correction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2024to 31 Mar 2032
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of progressive idiopathic scoliosis
- Preoperative major Cobb angle 30°-65°
- Preoperative flexibility to ≤30° on side bending radiograph (left or right)
- Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
- Failed or intolerant to bracing
- Signed informed consent and/or assent forms specific to this study
Who cannot join
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score of -1.5 or less
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
- Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
- Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shannon Bahn contact
United States2 sites, 2 recruiting
- Enrolling by invitation
New York University
New York, New York, 10016
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Angie Severson
Noelle Larson, MD
About this study
Official title: A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
Read the detailed description
The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.
- Conditions
- Idiopathic Scoliosis
- Being tested
- REFLECT Scoliosis Correction System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLECT Scoliosis Correction SystemDevice
The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.
| Study group | Role | What they receive |
|---|---|---|
| REFLECT | Other | Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device. Receives: Device: REFLECT Scoliosis Correction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Probable Benefit
Maintenance of major Cobb angle less than or equal to 40°
Measured: 60 months postoperative
Primary Safety
Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Measured: 60 months postoperative
Secondary outcomes (5)
Curve progression
Curve progression no greater than 10° of any secondary curve above or below the implant, or development of a new curve equal to or greater than 40°
Measured: 60 months postoperative
Device integrity
Device integrity failures including cord breakage and screw migration
Measured: 60 months postoperative
Composite endpoint analysis
Maintenance of major Cobb angle less than or equal to 40° AND freedom from Serious Adverse Events (SAEs) during the procedure and procedure/device related SAEs following surgery
Measured: 60 months postoperative
Failure analysis
Analysis of the failure attributable to conversion to another spinal implant OR major Cobb angle that exceeded 40° at defined follow-up visit OR any progression of the major curve at defined follow-up compared to baseline OR death OR permanent disability
Measured: 60 months postoperative
SRS score
Mean score of Scoliosis Research Society 22r Patient Questionnaire
Measured: 60 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start8 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2032 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients treated with the REFLECT Scoliosis Correction System
- Masking
- None (open label)
- 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
- NCT06298812
- Sponsor's protocol ID
- GMED.REF0723
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System
- ClinicalTrials.gov ID
- NCT06298812
- Acronym / sponsor ID
- GMED.REF0723
- Conditions
- Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 7 Mar 2024 (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.
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
Detailed description
The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients treated with the REFLECT Scoliosis Correction System
| Arm | Type | Receives |
|---|---|---|
| REFLECT | Other | Device: REFLECT Scoliosis Correction SystemEnrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of progressive idiopathic scoliosis
- Preoperative major Cobb angle 30°-65°
- Preoperative flexibility to ≤30° on side bending radiograph (left or right)
- Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
Key exclusion criteria (6 listed)
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score of -1.5 or less
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
- Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
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 |
|---|---|---|
| REFLECT Scoliosis Correction SystemThe REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. | Device | REFLECT |
Primary outcome
Primary Probable Benefit
Time frame: 60 months postoperative
Maintenance of major Cobb angle less than or equal to 40°
Primary Safety
Time frame: 60 months postoperative
Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
5 secondary outcomes
Curve progression
Time frame: 60 months postoperative
Device integrity
Time frame: 60 months postoperative
Composite endpoint analysis
Time frame: 60 months postoperative
Failure analysis
Time frame: 60 months postoperative
SRS score
Time frame: 60 months postoperative
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 13 Feb 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REFLECT Scoliosis Correction System in people with Idiopathic Scoliosis, run by Globus Medical Inc at 2 sites in United States.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Primary Probable Benefit (time frame: 60 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 13 Feb 2026.