NCT04885244 Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
| NCT ID | NCT04885244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Spine Study Group Foundation |
| Condition | Adult Spinal Deformity |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-07-28 |
| Primary Completion | 2034-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-07-28 with a primary completion date of 2034-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 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) AND Either: 5. One of the following Radiographic criteria: 1. PI-LL ≥ 25 degrees 2. Thoracolumbar/lumbar scoliosis ≥ 20 degrees 3. SVA \>10cm 4. PT \> 30 OR 6. One of the Following Procedural criteria: 1. Surgery to include \> 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone interbody. (Levels = vertebra (i.e. percutaneous screws at L2, L3, L4 would be eligible for posterior instrumentation and/or L3-L4, L4-L5 would be eligible as stand-alone for interbodies) 2. Posterior UIV and LIV must be placed percutaneously 3. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) 4. Staged ≥ 3 levels fused with percutaneous pedicle screws 5. 3 column osteotomy with percutaneous fixation 6. ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws Exclusion Criteria: 1. Deformity due to acute trauma 2. Active spine tumor or infection 3. Patient is unwilling or unable to complete questionnaires 4. Women who are pregnant 5. Prisoners 6. Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)
Contact & Investigator
Praveen Mummaneni, MD
PRINCIPAL INVESTIGATOR
University of San Francisco
Frequently Asked Questions
Who can join the NCT04885244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Spinal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04885244 currently recruiting?
Yes, NCT04885244 is actively recruiting participants. Contact the research team at baldusc@wustl.edu for enrollment information.
Where is the NCT04885244 trial being conducted?
This trial is being conducted at Phoenix, United States, La Jolla, United States, Los Angeles, United States, San Francisco, United States and 8 additional locations.
Who is sponsoring the NCT04885244 clinical trial?
NCT04885244 is sponsored by International Spine Study Group Foundation. The principal investigator is Praveen Mummaneni, MD at University of San Francisco. The trial plans to enroll 500 participants.