RECRUITING

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

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Conditions

Adult Spinal DeformityScoliosisKyphosisSagittal ImbalanceSpinal Deformity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-28
Study Completion:2034-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04885244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  1. 1. Deformity due to acute trauma
  2. 2. Active spine tumor or infection
  3. 3. Patient is unwilling or unable to complete questionnaires
  4. 4. Women who are pregnant
  5. 5. Prisoners -

Contacts and Locations

Study Contact

Christine Baldus, MS
CONTACT
6184444130
baldusc@wustl.edu
Ray Pinteric
CONTACT
ray.pinteric@outlook.com

Principal Investigator

Praveen Mummaneni, MD
PRINCIPAL_INVESTIGATOR
University of San Francisco
Paul Park, MD
PRINCIPAL_INVESTIGATOR
University of Michigan
Gregory Mundis, MD
PRINCIPAL_INVESTIGATOR
Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
Juan Uribe, MD
PRINCIPAL_INVESTIGATOR
Barrow Neurological Institute, Phoenix, AZ

Study Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California - San Francisco Medical Center
San Francisco, California, 94143
United States
University of Miami
Miami, Florida, 33125
United States
Rush University, Department of Neurosurgery
Chicago, Illinois, 60612
United States
Louisiana Spine Institute
Shreveport, Louisiana, 71101
United States
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, 48109
United States
Columbia University - New York-Presbyterian Och Spine Hospital
New York, New York, 10034
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Semmes-Murphey
Memphis, Tennessee, 38120
United States

Collaborators and Investigators

Sponsor: International Spine Study Group Foundation

  • Praveen Mummaneni, MD, PRINCIPAL_INVESTIGATOR, University of San Francisco
  • Paul Park, MD, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Gregory Mundis, MD, PRINCIPAL_INVESTIGATOR, Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
  • Juan Uribe, MD, PRINCIPAL_INVESTIGATOR, Barrow Neurological Institute, Phoenix, AZ

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28
Study Completion Date2034-12-31

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2034-12-31

Terms related to this study

Keywords Provided by Researchers

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance
  • Spinal Deformity

Additional Relevant MeSH Terms

  • Adult Spinal Deformity
  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance