← Back to Search

Procedure

Operative for Kyphosis (CADS Trial)

N/A
Recruiting
Led By Lawerence Lenke, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 1, 2, 5 & 10 year post treatment
Awards & highlights

CADS Trial Summary

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, 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
  • Kyphosis
  • Scoliosis
  • Adult Spinal Deformity

CADS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 1, 2, 5 & 10 year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 1, 2, 5 & 10 year post treatment for reporting.

Treatment Details

Study Objectives

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

CADS Trial Design

1Treatment groups
Experimental Treatment
Group I: OperativeExperimental Treatment1 Intervention
A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria 18 years of age or greater at the time of treatment Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) Complex patients are defined as and meeting any one of the subsequent criteria: a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment >7cm b. Procedural criteria: i. Posterior spinal fusion > 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Find a Location

Who is running the clinical trial?

SI-BONE, Inc.Industry Sponsor
12 Previous Clinical Trials
1,390 Total Patients Enrolled
International Spine Study Group FoundationLead Sponsor
5 Previous Clinical Trials
1,125 Total Patients Enrolled
3 Trials studying Kyphosis
825 Patients Enrolled for Kyphosis
MedtronicIndustry Sponsor
611 Previous Clinical Trials
828,438 Total Patients Enrolled
~280 spots leftby Dec 2031
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top