A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
ConditionIdiopathic Scoliosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGlobus Medical Inc
About this trial
This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.
Eligibility criteria
Qualifiers
Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis
Skeletally immature
Major Cobb angle of 30° and 65°
Bone structure adequate to safely accommodate screw fixation
Disqualifiers
Presence of any systemic infection, local infection, or skin compromise at the surgical site
Prior spinal surgery at the level(s) to be treated
Known poor bone quality, defined as a T-score of -1.5 or less
Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions
Trial design
Treatments tested in this trial
- Scoliosis Correction System
- Scoliosis Correction System
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov