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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
H210002 / PAS001 |
| Date Original Protocol Accepted |
07/13/2023
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| Date Current Protocol Accepted |
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| Study Name |
REFLECT Scoliosis Correction System Registry PAS
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| Device Name |
REFLECT™ Scoliosis Correction System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this multi-center, prospective, single-arm registry study is to evaluate radiographic and clinical outcomes of patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System.
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| Study Population |
Inclusion Criteria
Patients may be enrolled in the study if all of the following inclusion criteria are met:
Diagnosis of progressive idiopathic scoliosis
Preoperative major Cobb angle 30°-65°
Preoperative flexibility to less than or equal 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
Exclusion Criteria
Patients cannot be enrolled in the study if any of the following exclusion criteria are met:
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
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| Sample Size |
Number of subjects: 100 patients
Assumptions for sample size estimation: N/A
Number of sites: 5
Sites location: U.S. sites
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| Key Study Endpoints |
Primary Endpoints
The primary endpoints are deformity correction and safety, evaluated at 60 months postoperative, using the following:
• Primary probable benefit: maintenance of major Cobb angle less than or equal to 40°
• Primary safety: serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Secondary Outcomes:
Secondary outcome measures include the following evaluations at 60 months postoperative, compared to preoperative baseline where applicable:
• 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°
Device integrity failures including cord breakage and screw migration
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)
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
Mean score of Scoliosis Research Society 22r Patient Questionnaire
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| Follow-up Visits and Length of Follow-up |
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. The clinical evaluation schedule with follow-up windows (+/-2wk at 6wk; +/-1mo at 6mo; +/-2mo at 12; +/-4mo at 24 and 60mo) is provided in Appendix I.
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