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
This trial does not accept healthy volunteersQualifiers
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 population
Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Index or spine revision surgery for complex adult spinal deformity
Procedure/SurgerySurgical interventions will be patient specified by treating surgeon.
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Operative1 intervention
Trial outcomes
Primary outcomes
1
Scoliosis Research Society (SRS) 22r
Scoliosis specific patient reported outcome
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up2
Oswestry Disability Index (ODI)
Spine specific patient reported outcome
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up3
Veterans RAND 12 Item Health Survey (VR-12)
Patient reported outcome
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up4
Radiographic Evaluation
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-upSecondary outcomes
1
Edmonton Frail Scale
Evaluate frailty on scale of 0 to 17 where higher scores mean more frail
Time frame
Change from Preop to 3months and 1, 2, 5 & 10 year follow-up2
Canadian Study of Health and Aging (CSHA)
Frailty scale of 1 to 8; higher scores mean more frail
Time frame
Change from Preop to 3months and 1, 2, 5 & 10 year follow-up3
Adverse Events
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study
Time frame
3 months and 1, 2, 5 & 10 year post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
International Spine Study Group Foundation
Lead sponsor
Medtronic
Collaborator
Globus Medical Inc
Collaborator
SI-BONE, Inc.
Collaborator
Source ClinicalTrials.gov