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 — PROCEDURE
    Surgical 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: 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.

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

Locations (12)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Caleb Fisher
Juan Uribe, MD (PRINCIPAL_INVESTIGATOR)
Jay Turner, MD (SUB_INVESTIGATOR)
Shiley Center for Orthopaedic Research and Education at Scripps ClinicLa JollaCalifornia92037
Paulina de la Garza
858-554-7124
Gregory Mundis, MD (PRINCIPAL_INVESTIGATOR)
Robert Eastlack, MD (SUB_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Babak Khanderoo
Neel Anand, MD (PRINCIPAL_INVESTIGATOR)
University of California - San Francisco Medical CenterSan FranciscoCalifornia94143
Catherine Ravikumar
Praveen Mummaneni, MD (PRINCIPAL_INVESTIGATOR)
Nima Alan, MD (SUB_INVESTIGATOR)
University of MiamiMiamiFlorida33125
Adriana Saravia
Micahael Wang, MD (PRINCIPAL_INVESTIGATOR)
Rush University, Department of NeurosurgeryChicagoIllinois60612
Reehan Malhance
Richard Fessler, MD (PRINCIPAL_INVESTIGATOR)
Louisiana Spine InstituteShreveportLouisiana71101
Cody McConnell
Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan, Department of NeurosurgeryAnn ArborMichigan48109-
Columbia University - New York-Presbyterian Och Spine HospitalNew YorkNew York10034
Dean Chou, MD (PRINCIPAL_INVESTIGATOR)
Duke University Health SystemDurhamNorth Carolina27710
Ronald Pegues
Khoi Than, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Jan Alicandro
David Okonkwo, MD (PRINCIPAL_INVESTIGATOR)
Kojo Hamilton, MD (SUB_INVESTIGATOR)
Semmes-MurpheyMemphisTennessee38120
Sarah Lafferty
Paul Park, MD (PRINCIPAL_INVESTIGATOR)

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