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N/A

Operative for Scoliosis (MIS Trial)

N/A
Recruiting
Led By Paul Park, MD
Research Sponsored by International Spine Study Group Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA \>10cm iv. PT \> 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from preop to 3 months and 1, 2, 5 & 10 year follow-up
Awards & highlights

Summary

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.

Eligible Conditions
  • Scoliosis
  • Kyphosis
  • Adult Spinal Deformity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from preop to 3 months and 1, 2, 5 & 10 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from preop to 3 months and 1, 2, 5 & 10 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oswestry Disability Index (ODI)
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
+9 more
Secondary study objectives
Adverse Events
Canadian Study of Health and Aging (CSHA)
Edmonton Frail Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: OperativeExperimental Treatment1 Intervention
Multicenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months.

Find a Location

Who is running the clinical trial?

International Spine Study Group FoundationLead Sponsor
5 Previous Clinical Trials
1,125 Total Patients Enrolled
3 Trials studying Scoliosis
825 Patients Enrolled for Scoliosis
NuVasiveIndustry Sponsor
43 Previous Clinical Trials
27,065 Total Patients Enrolled
6 Trials studying Scoliosis
11,495 Patients Enrolled for Scoliosis
Paul Park, MDPrincipal InvestigatorUniversity of Michigan
~333 spots leftby Dec 2034
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