Complex Adult Deformity Surgery (CADS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInternational Spine Study Group Foundation
About 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.
Eligibility criteria
Qualifiers
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
TPA ≥ 30 degrees
Disqualifiers
Age <18 years of age
Active spine tumor or infection
Deformity due to acute trauma
Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
Trial design
Treatments tested in this trial
- Index or spine revision surgery for complex adult spinal deformity
Treatment groups
1,500 Participants
are divided into 1 treatment groupSponsors and collaborators
International Spine Study Group Foundation
Lead sponsor
Medtronic
Collaborator
Globus Medical Inc
Collaborator
SI-BONE, Inc.
Collaborator
Source ClinicalTrials.gov