Complex Adult Deformity Surgery (CADS)

(CADS Trial)

Recruiting at 18 trial locations

Overseen By Ray Pinteric

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: International Spine Study Group Foundation

Disqualifiers: Neuromuscular diseases, Inflammatory arthritis, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Christopher Shaffrey, MD

Principal Investigator

Duke University, Departments of Neurosurgery and Orthopaedic Surgery

Shay Bess, MD

Principal Investigator

Denver International Spine Center

Lawrence Lenke, MD

Principal Investigator

Columbia University, Department of Orthopedic Surgery

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity

Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)

PI-LL ≥ 25 degrees

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative assessments including radiographic evaluations and frailty assessments

4 weeks

Surgical Treatment

Participants receive surgical treatment for complex adult spinal deformity

Hospital stay >9 days

Postoperative Monitoring

Participants are monitored for surgical and postoperative complications, and outcomes are evaluated using various patient-reported outcome measures

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 1, 2, 5, and 10 years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Index or Spine Revision Surgery for Complex Adult Spinal Deformity

How Is the Trial Designed?

Group I: Operative Experimental Treatment 1 Intervention

A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria 1. 18 years of age or greater at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity 3. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) 4. 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

Who Is Running the Clinical Trial?

International Spine Study Group Foundation

Lead Sponsor

Trials

6

Recruited

1,600+

SI-BONE, Inc.

Industry Sponsor

Trials

14

Recruited

2,800+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Globus Medical Inc

Industry Sponsor

Trials

17

Recruited

2,300+