A New Normative Zone for Acetabular Anteversion Positioning in ASD Patients.
Marc Boutros, Ayman Assi, Bassel G Diebo...
https://pubmed.ncbi.nlm.nih.gov/41761562Actively Recruiting
Led by International Spine Study Group Foundation · Updated on 2026-02-17
1500
Participants Needed
18
Research Sites
186 weeks
Total Duration
I
International Spine Study Group Foundation
Lead Sponsor
M
Medtronic
Collaborating Sponsor
Researchers are evaluating surgical outcomes and best practice guidelines for adults with complex spinal deformities. This study focuses on patients with adult spinal deformity (ASD), examining radiographic and clinical results, surgical and postoperative complications, risk factors for revision surgeries, and the impact of standard care processes on improving patient outcomes and reducing complications. The research aims to develop a universal system for classifying spine surgery complications and to understand factors affecting costs and mental health in ASD patients. The study involves multicenter, prospective observation of adults undergoing surgery for complex ASD, including those with congenital, degenerative, idiopathic, or iatrogenic spinal deformities. Complex cases are defined by specific radiographic measurements, extensive spinal fusion procedures, or geriatric criteria. Surgical interventions are determined by each patient's treating surgeon and may include procedures like three-column osteotomies or anterior column reconstruction. Researchers also assess blood management, opioid use, frailty, and mental health as parts of the treatment process. Participants will undergo full-body EOS radiographic assessments before surgery, with follow-up evaluations at 3 months, 1, 2, 5, and 10 years. Outcomes are measured using various tools including the Scoliosis Research Society 22r questionnaire, Oswestry Disability Index, Veterans RAND 12, and PROMIS scales for anxiety, depression, pain, physical function, and social satisfaction. The study also tracks adverse events, frailty scores, and hospital stay lengths to understand long-term clinical and social health outcomes. The study will continue monitoring participants through 2032 to gather comprehensive data on surgical effectiveness and patient well-being.
CONDITIONS
Complex Adult Deformity Surgery (CADS)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration varies, typically over 9 days
Participants undergo complex adult spinal deformity surgery as specified by their treating surgeon, including procedures such as 3 column osteotomies and anterior column reconstruction. Surgical and immediate post-operative care are provided to manage recovery and complications.
Hospital stay with daily in-person assessments
Duration - Up to 10 years following surgery
Participants attend scheduled follow-up visits to assess surgical outcomes, complications, and recovery progress. Clinical and radiographic evaluations, as well as patient-reported outcome measures, are collected over time to monitor improvement and long-term results.
Visits at 3 months, 1 year, 2 years, 5 years, and 10 years post-surgery
Total: 18 locations
1
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California, Davis, Department of Orthopedic Surgery
Sacramento, California, United States, 05616
Active, Not Recruiting
3
UCSF, Department of Neurosurgery
San Francisco, California, United States, 94143
Actively Recruiting
4
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
5
University of Kansas, Department of Orthopedic Surgery
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
Norton Leatherman Spine Center
Louisville, Kentucky, United States, 40207
Actively Recruiting
7
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Actively Recruiting
8
John Hopkins University, Department of Orthopedic Surgery
Baltimore, Maryland, United States, 21224
Actively Recruiting
9
NYU, Department of Orthopedics
New York, New York, United States, 10016
Actively Recruiting
10
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New York, United States, 10021
Actively Recruiting
11
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Northwell Health
New York, New York, United States, 10075
Actively Recruiting
13
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
14
University Orthopedics
Providence, Rhode Island, United States, 02905
Actively Recruiting
15
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texas, United States, 75243
Actively Recruiting
16
University of Texas - Houston
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
18
Toronto Western
Toronto, Ontario, Canada
Actively Recruiting
C
Christine Baldus, MS
R
Ray Pinteric
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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