REFLECT Scoliosis System Post Approval Study

Launched by GLOBUS MEDICAL INC · Mar 1, 2024

Keywords

ClinConnect Summary

The REFLECT Scoliosis System Post Approval Study is designed to learn more about how well the REFLECT™ Scoliosis Correction System works for patients with idiopathic scoliosis, a condition where the spine curves abnormally. This study will follow 100 patients who are treated with this system to see how their spine changes over time and how they feel after the surgery. The study is not yet recruiting participants, but it aims to evaluate the outcomes of this treatment as part of the approval process to ensure it's safe and effective.

To be eligible for this study, participants must be diagnosed with progressive idiopathic scoliosis and have a specific range of spine curvature before surgery. They should also be young and still growing, which is indicated by certain measures of bone maturity. Additionally, candidates must have previously struggled with bracing treatment and should be healthy enough to undergo surgery. Participants will need to sign consent forms and are expected to attend follow-up visits to track their recovery. This study is important because it will help doctors understand the benefits and risks of this new treatment option for scoliosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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