Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- International Spine Study Group Foundation
- Study ID
- NCT04885244
- Status
- Recruiting
Conditions
- Adult Spinal Deformity
- Kyphosis
- Sagittal Imbalance
- Scoliosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Index or spine revision surgery for complex adult spinal deformity — PROCEDURESurgical interventions will be patient specified by treating surgeon.
Study Details
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.
Key Dates
- Start date
- Jul 28, 2021
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2034
- Completion
- Dec 31, 2034
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: OperativeMulticenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months.
Primary Outcome Measure
Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
Central Contacts
- Christine Baldus, MS6184444130
- Ray Pinteric
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | Caleb Fisher Juan Uribe, MD (PRINCIPAL_INVESTIGATOR) Jay Turner, MD (SUB_INVESTIGATOR) |
| Shiley Center for Orthopaedic Research and Education at Scripps Clinic | La Jolla | California | 92037 | Gregory Mundis, MD (PRINCIPAL_INVESTIGATOR) Robert Eastlack, MD (SUB_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Babak Khanderoo Neel Anand, MD (PRINCIPAL_INVESTIGATOR) |
| University of California - San Francisco Medical Center | San Francisco | California | 94143 | Catherine Ravikumar Praveen Mummaneni, MD (PRINCIPAL_INVESTIGATOR) Nima Alan, MD (SUB_INVESTIGATOR) |
| University of Miami | Miami | Florida | 33125 | Adriana Saravia Micahael Wang, MD (PRINCIPAL_INVESTIGATOR) |
| Rush University, Department of Neurosurgery | Chicago | Illinois | 60612 | Reehan Malhance Richard Fessler, MD (PRINCIPAL_INVESTIGATOR) |
| Louisiana Spine Institute | Shreveport | Louisiana | 71101 | Cody McConnell Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan, Department of Neurosurgery | Ann Arbor | Michigan | 48109 | - |
| Columbia University - New York-Presbyterian Och Spine Hospital | New York | New York | 10034 | Vivian Le Dean Chou, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Health System | Durham | North Carolina | 27710 | Ronald Pegues Khoi Than, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Jan Alicandro David Okonkwo, MD (PRINCIPAL_INVESTIGATOR) Kojo Hamilton, MD (SUB_INVESTIGATOR) |
| Semmes-Murphey | Memphis | Tennessee | 38120 | Sarah Lafferty Paul Park, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Phoenix, AZ
By research site
Barrow Neurological Institute· Phoenix, AZShiley Center for Orthopaedic Research and Education at Scripps Clinic· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAUniversity of California - San Francisco Medical Center· San Francisco, CAUniversity of Miami· Miami, FLRush University, Department of Neurosurgery· Chicago, IL
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