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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of skeletally immature pediatric and adolescent patients with progressive idiopathic scoliosis who were treated surgically with the REFLECT™ Scoliosis Correction System as part of routine clinical care. Eligible patients had a major spinal curve between 30° and 65°, required surgical correction after failing or being unable to tolerate bracing, and had adequate bone quality to support screw fixation. This is a multicenter, international retrospective cohort including approximately 100 patients treated at participating institutions in Germany, Turkey, and the United States. The cohort includes patients treated with either 4.0 mm or 5.0 mm REFLECT cords, using single or dual cords per curve, with at least 12 months of postoperative clinical and radiographic follow-up available for review.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Scoliosis Correction System
DeviceThe REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 4.0 mm cord diameter was used to treat patients.
Scoliosis Correction System
DeviceThe REFLECT system is a non-fusion spinal device, meaning it corrects scoliosis without permanently fusing the spine. Instead of rigid metal rods, it uses a flexible polymer cord attached to screws. For this intervention, a 5.0 mm cord diameter was used to treat patients.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: 4.0 Group1 intervention
Group B: 5.0 Group1 intervention
Trial outcomes
Primary outcomes
1
REFLECT Cord Breakage/Separation
Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords
Time frame
by latest available time point (minimum 12 months postoperative)2
Subsequent Surgeries Related to Cord Breakage
Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation
Time frame
by latest available time point (minimum 12 months postoperative)Secondary outcomes
1
Complications Profile
Rate of all complications attributable to the REFLECT system
Time frame
up to the latest available follow-up visit, with a required minimum of 12 months after surgery.2
All Subsequent Surgeries
Rate of all subsequent surgeries at the treatment levels that are associated with the REFLECT system
Time frame
up to the latest available follow-up visit, with a required minimum of 12 months after surgery.3
Change in Curve
Change in curve(s), as measured by the change in Cobb angle(s)
Time frame
From baseline (preoperative) to each postoperative time point.Sponsors and contacts
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Source ClinicalTrials.gov
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