REFLECT System for Idiopathic Scoliosis

Overseen By Jacqueline Myer, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Globus Medical Inc

Disqualifiers: Prior spinal surgery, Poor bone quality, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

100 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the REFLECT Scoliosis Correction System treatment for idiopathic scoliosis?

The SpineCor System, a dynamic brace for idiopathic scoliosis, showed that 74.2% of patients had successful treatment outcomes, with most maintaining positive results two years after treatment. This suggests that dynamic correction systems can be effective for scoliosis, which may support the potential effectiveness of the REFLECT Scoliosis Correction System. ^{1 2 3 4 5}

What safety data exists for the REFLECT System for Idiopathic Scoliosis?

There is a study on a similar treatment for scoliosis that found a reoperation rate of 4.5% to 8.8% due to issues like rod breakage and screw pullout, which required additional surgery. This suggests that while the treatment can have complications, it is generally considered safe enough to be used in patients. ^{6 7 8 9 10}

How is the REFLECT Scoliosis Correction System treatment different from other scoliosis treatments?

The REFLECT Scoliosis Correction System is unique because it likely involves a novel approach to correcting spinal deformities, potentially using advanced imaging or dynamic systems to achieve better 3D correction of the spine, unlike traditional methods that may rely solely on static braces or surgery. ^{11 12 13 14 15}

What is the purpose of 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 is for 100 patients with idiopathic scoliosis. Specific details about who can join are not provided, but typically participants would have a diagnosis of scoliosis and meet certain health standards set by the study.

Inclusion Criteria

My condition is worsening scoliosis without a known cause.

Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging

Failed or intolerant to bracing

Exclusion Criteria

I do not have any infections or skin issues at the surgery area.

Documented poor bone quality, defined as a T-score of -1.5 or less

I have had spinal surgery at the same spot that needs treatment now.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative evaluations and preparations for surgery

1-2 weeks

1 visit (in-person)

Intraoperative

Surgical treatment with the REFLECT Scoliosis Correction System

1 day

1 visit (in-person)

Immediate Postoperative

Initial recovery and assessment after surgery

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Visits at 6 weeks, 6 months, 12 months, 24 months, and 60 months

Treatment Details

Interventions

• REFLECT Scoliosis Correction System

Trial Overview The REFLECT Scoliosis Correction System is being evaluated in this study. It's a single-arm registry Post-Approval Study (PAS) to assess radiographic and clinical outcomes in patients treated with this system after it has been approved.

Participant Groups

Group I: REFLECT Experimental Treatment 1 Intervention

Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.

Who Is Running the Clinical Trial?

Globus Medical Inc

Lead Sponsor

Trials

17

Recruited

2,300+

Findings from Research

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of early adolescent idiopathic scoliosis using the SpineCor System. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Changes in surface and radiographic deformity after Universal Spine System for right thoracic adolescent idiopathic scoliosis: is rib-hump reassertion a mechanical problem of the thoracic cage rather than an effect of relative anterior spinal overgrowth? [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Research advancement of three-dimensional correction techniques of idiopathic scoliosis]. [2012]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Development of CAD/CAM Based Brace Models for the Treatment of Patients with Scoliosis-Classification Based Approach versus Finite Element Modelling. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Prospective US FDA IDE Pilot Study of Titanium Clip-Screw Implant at Two to Five Years. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? [2018]

8. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Dissecting the effects of spinal fusion and deformity magnitude on quality of life in patients with adolescent idiopathic scoliosis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Wisconsin and other instrumentation for posterior spinal fusion. [2005]

11. China pubmed.ncbi.nlm.nih.gov

[Current development of correction of severe and rigid scoliosis]. [2012]

12. France pubmed.ncbi.nlm.nih.gov

[Surgery of scoliosis. Decision aid by three-dimensional imaging (3D)]. [2016]

13. China pubmed.ncbi.nlm.nih.gov

[The preliminary clinical application of a smart orthosis personalized management system for the treatment of patients with adolescent idiopathic scoliosis]. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional correction of scoliosis by a double spring reduction system as a dynamic internal brace: a pre-clinical study in Göttingen minipigs. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Dynamic positioning of scoliotic patients during spine instrumentation surgery. [2019]