Surgery for Adult Spinal Deformity
(CADS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of surgery for adults with complex spine problems that cause unusual curvature or twisting. The goal is to identify the best surgical techniques and improve post-surgery outcomes. Suitable candidates have a diagnosed spine deformity causing daily discomfort and requiring complex surgery, such as large spinal curves or extensive spinal fusion. Researchers will observe participants to assess recovery and the need for additional surgeries, like index or spine revision surgery for complex adult spinal deformity.
As a Phase 2 trial, this research focuses on evaluating the effectiveness of surgical techniques in an initial, smaller group, offering participants a chance to contribute to advancements in spine surgery.
Will I have to stop taking my current medications?
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 prior data suggests that this surgical treatment is safe for complex adult spinal deformity patients?
Research has shown that surgery for complex adult spinal deformity can be difficult and may involve risks. Studies have found high rates of complications during and after these surgeries. Common issues include wound infections and other problems that might require additional medical care. However, efforts aim to make these surgeries safer and reduce these risks. Prospective participants should consider these risks and discuss them with their doctor.12345
Why are researchers excited about this trial?
Researchers are excited about the surgical options for complex adult spinal deformity because the trial focuses on index or spine revision surgeries tailored to severe cases that conventional surgeries may not fully address. Unlike standard procedures, this approach involves extensive spinal fusion and advanced techniques like three-column osteotomy, which can correct significant spinal misalignments. Moreover, the comprehensive full-body radiographic assessments ensure precise targeting of spinal deformities, potentially leading to better alignment and improved patient outcomes.
What evidence suggests that this surgical treatment is effective for complex adult spinal deformity?
Research has shown that surgery for complex adult spinal deformity (ASD), which participants in this trial may undergo, can significantly improve quality of life. Studies have found that these surgeries enhance posture and reduce pain. Many patients report feeling healthier and happier afterward. Evidence indicates that, on average, patients experience less pain and can engage in more daily activities. Although complications can occur, research strongly supports the overall benefits of surgery for ASD.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants undergo preoperative assessments including radiographic evaluations and frailty assessments
Surgical Treatment
Participants receive surgical treatment for complex adult spinal deformity
Postoperative Monitoring
Participants are monitored for surgical and postoperative complications, and outcomes are evaluated using various patient-reported outcome measures
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 1, 2, 5, and 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?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
International Spine Study Group Foundation
Lead Sponsor
SI-BONE, Inc.
Industry Sponsor
Medtronic
Industry Sponsor
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
Citations
NCT04194138 | Complex Adult Deformity Surgery (CADS)
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and ...
Impact of spine surgery complications on costs associated ...
Approaches to clinical management of patients with adult spinal deformity (ASD) can be broadly categorized into nonoperative and operative care. Nonoperative ...
Outcomes of operative treatment for adult spinal deformity
OBJECTIVE. The current literature has primarily focused on the 2-year outcomes of operative adult spinal deformity (ASD) treatment.
Patient-Reported Outcomes After Adult Spinal Deformity ...
Background: Surgical treatment of adult spinal deformity (ASD) can significantly improve health-related quality of life (HRQoL) but is ...
Patient Reported Outcomes in Adult Spinal Deformity Surgery
Studies of outcomes in adult spinal deformity surgery (ASD) demonstrate treatment effectiveness and enable healthcare providers and patients to make informed ...
Perioperative Medical Complications in Adult Spine ...
Neurologic outcomes of complex adult spinal deformity surgery: results of the prospective, multicenter Scoli-RISK-1 study. Spine. 2016;41(3): ...
Revision Rate After Adult Deformity Surgery
Historically, surgical treatment of adult spinal deformity was limited by inadequate correction and high complication rates.
Quality metrics in adult spinal deformity surgery over the last ...
The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of ...
9.
orangeflux.corp-images.net
orangeflux.corp-images.net/safetyinspine/wp-content/uploads/2017/11/Sethi_et_al_JNS_Spine_2017.pdfA systematic multidisciplinary initiative for reducing the risk of ...
spinal deformity (ASD) are challenging procedures with high rates of intraoperative and postoperative morbidity, including wound infections and ...
Complex Adult Deformity Surgery (CADS) - Clinical Trial Finder
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and ...
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