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

NCT04885244 | Recruiting

• 1 other identifier: 2138
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Adult Spinal Deformity; Kyphosis; Scoliosis; Sagittal Imbalance

Keywords

Scoliosis; Kyphosis; Sagittal Imbalance; Spinal Deformity

Outcome Measures

Primary Outcomes (12)

• Scoliosis Research Society (SRS) 22r

  Scoliosis specific patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Oswestry Disability Index (ODI)

  Spine specific patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Veterans RAND 12 Item Health Survey (VR-12)

  Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction

  Computer adaptive Patient reported outcome

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Radiographic Evaluation

  Cobb angles, Coronal \& Sagittal balance, spinopelvic measures

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Visual Analog Scale - Back Pain

  Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

• Visual Analog Scale - Leg pain

  Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

Secondary Outcomes (3)

• Edmonton Frail Scale

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]

• Canadian Study of Health and Aging (CSHA)

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]

• Adverse Events

  Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]

Study Arms (1)

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.

Procedure: Index or spine revision surgery for complex adult spinal deformity

Interventions

Index or spine revision surgery for complex adult spinal deformity PROCEDURE

Surgical interventions will be patient specified by treating surgeon.

Operative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients

You may qualify if:

• \>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

You may not qualify if:

• Deformity due to acute trauma
• Active spine tumor or infection
• Patient is unwilling or unable to complete questionnaires
• Women who are pregnant
• Prisoners
• Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)

Sponsors & Collaborators

• International Spine Study Group Foundation: lead
• NuVasive: collaborator

Study Sites (12)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California - San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

University of Miami

Miami, Florida, 33125, United States

RECRUITING

Rush University, Department of Neurosurgery

Chicago, Illinois, 60612, United States

RECRUITING

Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States

RECRUITING

University of Michigan, Department of Neurosurgery

Ann Arbor, Michigan, 48109, United States

COMPLETED

Columbia University - New York-Presbyterian Och Spine Hospital

New York, New York, 10034, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Semmes-Murphey

Memphis, Tennessee, 38120, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Praveen Mummaneni, MD

  University of San Francisco

  PRINCIPAL INVESTIGATOR

• Paul Park, MD

  Semmes-Murphey Clinic

  PRINCIPAL INVESTIGATOR

• Gregory Mundis, MD

  Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA

  PRINCIPAL INVESTIGATOR

• Juan Uribe, MD

  Barrow Neurological Institute, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Baldus, MS

CONTACT

6184444130; baldusc@wustl.edu

Ray Pinteric

CONTACT

ray.pinteric@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: July 28, 2021
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)