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
Qualifiers
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
Treatments tested in this trial
- REFLECT Scoliosis Correction System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov