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Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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)

• AND Either:

• One of the following Radiographic criteria:

‣ PI-LL ≥ 25 degrees

⁃ Thoracolumbar/lumbar scoliosis ≥ 20 degrees

⁃ SVA \>10cm

⁃ PT \> 30 OR

• One of the Following Procedural criteria:

‣ 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)

⁃ Posterior UIV and LIV must be placed percutaneously

⁃ Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not)

⁃ Staged ≥ 3 levels fused with percutaneous pedicle screws

⁃ 3 column osteotomy with percutaneous fixation

⁃ ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws

Locations
United States
Arizona
Barrow Neurological Institute
RECRUITING
Phoenix
California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of California - San Francisco Medical Center
RECRUITING
San Francisco
Florida
University of Miami
RECRUITING
Miami
Illinois
Rush University, Department of Neurosurgery
RECRUITING
Chicago
Louisiana
Louisiana Spine Institute
RECRUITING
Shreveport
Michigan
University of Michigan, Department of Neurosurgery
COMPLETED
Ann Arbor
North Carolina
Duke University Health System
RECRUITING
Durham
New York
Columbia University - New York-Presbyterian Och Spine Hospital
RECRUITING
New York
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
Semmes-Murphey
RECRUITING
Memphis
Contact Information
Primary
Christine Baldus, MS
baldusc@wustl.edu
6184444130
Backup
Ray Pinteric
ray.pinteric@outlook.com
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 500
Treatments
Operative
Multicenter, 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.
Authors
Kai-Ming Fu, Adam Kanter
Related Therapeutic Areas
Sponsors
Collaborators: NuVasive
Leads: International Spine Study Group Foundation

This content was sourced from clinicaltrials.gov