Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
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 treated with minimally invasive approach, 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
>18 years of age at the time of treatment
Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity
EOS full body or standing 36" AP & Lateral images of entire spine
Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected)
Disqualifiers
Deformity due to acute trauma
Active spine tumor or infection
Patient is unwilling or unable to complete questionnaires
Women who are pregnant
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
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
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Computer adaptive Patient reported outcome
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 3 months and 1, 2, 5 & 10 year follow-up]2
Canadian Study of Health and Aging (CSHA)
Frailty scale of 1 to 9; higher scores mean more frail
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]3
Adverse Events
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study
Time frame
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
International Spine Study Group Foundation
Lead sponsor
NuVasive
Collaborator
Source ClinicalTrials.gov