REFLECT Scoliosis System Post Approval Study
ConditionIdiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGlobus Medical Inc
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
REFLECT Scoliosis Correction System
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: REFLECTOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary Probable Benefit
Maintenance of major Cobb angle less than or equal to 40°
Time frame
60 months postoperative2
Primary Safety
Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Time frame
60 months postoperativeSecondary outcomes
1
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°
Time frame
60 months postoperative2
Device integrity
Device integrity failures including cord breakage and screw migration
Time frame
60 months postoperative3
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
Time frame
60 months postoperative4
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
Time frame
60 months postoperativeSponsors and contacts
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Source ClinicalTrials.gov