Status:
RECRUITING
Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
Lead Sponsor:
International Spine Study Group Foundation
Collaborating Sponsors:
NuVasive
Conditions:
Adult Spinal Deformity
Scoliosis
Eligibility:
All Genders
18+ years
Brief Summary
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinic...
Detailed Description
Specific Aims: * Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radio...
Eligibility Criteria
Inclusion
- 1\. \>18 years of age at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity 3. EOS full body or standing 36" AP \& Lateral images of entire spine 4. Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected) 5. Surgery to include \> 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone lateral 6. And any one of the following:
- a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA \>10cm iv. PT \> 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation
Exclusion
- Deformity due to acute trauma
- Active spine tumor or infection
- Patient is unwilling or unable to complete questionnaires
- Women who are pregnant
- Prisoners -
Key Trial Info
Start Date :
July 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2034
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04885244
Start Date
July 28 2021
End Date
December 31 2034
Last Update
March 5 2024
Active Locations (12)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143