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RecruitingNCT04885244MISUpdated Feb 17, 2026

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

An observational study in Adult Spinal Deformity, Scoliosis and Kyphosis, sponsored by International Spine Study Group Foundation. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by International Spine Study Group Foundation · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Specific Aims:

  • 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.

    a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria.

  • Develop and validate a standardized, universal complications classification system for minimally invasive spine surgery
  • Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for minimally invasive adult spinal deformity surgery
  • Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including Scoliosis Research Society 22r (SRS 22r) modified Oswestry Disability Index (mODI), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS), and patient reported outcome measurement information system (PROMIS).
  • Evaluate clinical outcomes stratifying by patient chronological and physiological age
  • Evaluate the cost for episode of care for minimally invasive CADS surgery and cost per QALY gain compared to open surgery for CADS
  • Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications
  • Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients treated with MIS techniques, and establish best practice guidelines for assessing MH
  • Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery
  • Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility
  • Broaden the evaluation of the minimally invasive surgically treated ASD patient to maximize evaluation of the entirety of the episode of care to include steps that can be taken prior to surgery including "prehabilitation," pain management, and MH care to improve treatment outcomes, reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce early and late complications
  • Establish a core set of standard work guidelines to clinically and radiographically evaluate and treat ASD patients and evaluate the utility of standard work to improve outcomes for ASD and formulate best practice guidelines for minimally invasive surgical treatment of ASD
  • Evaluate the use of robotic techniques in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes
  • Evaluate the use of expandable cages in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes
  • Evaluate the OR efficiency, morbidity of surgery, and cost per episode of care relating to single-position vs. multi-position CADS surgery
  • Evaluate the prevalence and incidence of sacroiliac pain before/after complex adult spinal deformity surgery.
02

Conditions studied

  • Adult Spinal Deformity
  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance

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Keywords

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance
  • Spinal Deformity
03

In context

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's planned enrollment of 500 is above the median of 84 across 256 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

International Spine Study Group Foundation is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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)

    AND Either:

  5. One of the following Radiographic criteria:

    1. PI-LL ≥ 25 degrees
    2. Thoracolumbar/lumbar scoliosis ≥ 20 degrees
    3. SVA >10cm
    4. PT > 30 OR

  6. One of the Following Procedural criteria:

    1. 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)
    2. Posterior UIV and LIV must be placed percutaneously
    3. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not)
    4. Staged ≥ 3 levels fused with percutaneous pedicle screws
    5. 3 column osteotomy with percutaneous fixation
    6. ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws

Exclusion criteria

Exclusion Criteria:

  1. Deformity due to acute trauma
  2. Active spine tumor or infection
  3. Patient is unwilling or unable to complete questionnaires
  4. Women who are pregnant
  5. Prisoners
  6. Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureIndex or spine revision surgery for complex adult spinal deformity

    Surgical interventions will be patient specified by treating surgeon.

06

What researchers measure

Primary outcomes

  1. Scoliosis Research Society (SRS) 22r

    Scoliosis specific patient reported outcome

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

  2. Oswestry Disability Index (ODI)

    Spine specific patient reported outcome

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

  3. Veterans RAND 12 Item Health Survey (VR-12)

    Patient reported outcome

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

  4. Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

    Computer adaptive Patient reported outcome

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

  5. Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

    Computer adaptive Patient reported outcome

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

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

    Computer adaptive Patient reported outcome

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

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

    Computer adaptive Patient reported outcome

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

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

    Computer adaptive Patient reported outcome

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

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

    Computer adaptive Patient reported outcome

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

  10. Radiographic Evaluation

    Cobb angles, Coronal \& Sagittal balance, spinopelvic measures

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

  11. Visual Analog Scale - Back Pain

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

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

  12. Visual Analog Scale - Leg pain

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

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

Secondary outcomes

  1. Edmonton Frail Scale

    Evaluate frailty on scale of 0 to 17 where higher scores mean more frail

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

  2. Canadian Study of Health and Aging (CSHA)

    Frailty scale of 1 to 9; higher scores mean more frail

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

  3. Adverse Events

    Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study

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

07

Study locations

11 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04885244
Lead sponsor
International Spine Study Group Foundation
Collaborators
NuVasive
Responsible party
Sponsor
First posted
May 13, 2021
Start date
Jul 28, 2021
Primary completion
Dec 31, 2034 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Feb 17, 2026

Study contacts

Christine Baldus, MS
Contact
baldusc@wustl.edu
6184444130
Ray Pinteric
Contact
ray.pinteric@outlook.com
Praveen Mummaneni, MD
principal investigator · University of San Francisco
Paul Park, MD
principal investigator · Semmes-Murphey Clinic
Gregory Mundis, MD
principal investigator · Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
Juan Uribe, MD
principal investigator · Barrow Neurological Institute, Phoenix, AZ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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