Adult Spinal DeformityMISNCT04885244
Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
An observational study of Adult Spinal Deformity and Scoliosis, run by International Spine Study Group Foundation at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Spinal Deformity, Scoliosis, Kyphosis
- What is being tested?
- Index or spine revision surgery for complex adult spinal deformity
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 Jul 2021to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients
Who may be able to join
- >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:
Show all 17Show fewer
- 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
- 3 column osteotomy with percutaneous fixation
- ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws
Who cannot join
- 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)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ray Pinteric contact
12 sites in 1 country
United States12 sites, 11 recruiting
- Completed
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, 48109
- Recruiting
Rush University, Department of Neurosurgery
Chicago, Illinois, 60612
Reehan Malhance, Reehan_T_Malhance@rush.edu
Richard Fessler, MD
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Ronald Pegues, ronald.pegues@duke.edu
Khoi Than, MD
- Recruiting
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037
Paulina de la Garza, 858-554-7124, delaGarza.Paulina@scrippshealth.org
Gregory Mundis, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Babak Khanderoo, babakk70@gmail.com
Neel Anand, MD
- Recruiting
Semmes-Murphey
Memphis, Tennessee, 38120
Sarah Lafferty, slafferty@semmes-murphey.com
Paul Park, MD
- Recruiting
University of Miami
Miami, Florida, 33125
Adriana Saravia, axf1724@med.miami.edu
Micahael Wang, MD
- Recruiting
Columbia University - New York-Presbyterian Och Spine Hospital
New York, New York, 10034
Vivian Le, vl2518@cumc.columbia.edu
Dean Chou, MD
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Caleb Fisher, caleb.fisher900@commonspirit.org
Juan Uribe, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jan Alicandro, alicandroja@upmc.edu
David Okonkwo, MD
- Recruiting
University of California - San Francisco Medical Center
San Francisco, California, 94143
Catherine Ravikumar, Catherine.Ravikumar@ucsf.edu
Praveen Mummaneni, MD
- Recruiting
Louisiana Spine Institute
Shreveport, Louisiana, 71101
Cody McConnell, CMcConnell@louisianaspine.org
Pierce Nunley, MD
About this study
Official title: Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)
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.
- 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.
- Conditions
- Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance
- Being tested
- Index or spine revision surgery for complex adult spinal deformity
- Keywords
- Scoliosis, Kyphosis, Sagittal Imbalance, Spinal Deformity
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index or spine revision surgery for complex adult spinal deformityProcedure or surgery
Surgical interventions will be patient specified by treating surgeon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Index or spine revision surgery for complex adult spinal deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Research Society (SRS) 22r
Scoliosis specific patient reported outcome
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Oswestry Disability Index (ODI)
Spine specific patient reported outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Radiographic Evaluation
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
Measured: 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)
Measured: 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)
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary outcomes (3)
Edmonton Frail Scale
Evaluate frailty on scale of 0 to 17 where higher scores mean more frail
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Canadian Study of Health and Aging (CSHA)
Frailty scale of 1 to 9; higher scores mean more frail
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Adverse Events
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study
Measured: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start28 Jul 2021
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Spine Study Group Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- NuVasive
- Responsible party
- Sponsor
- Investigators
- Praveen Mummaneni, MD, Principal investigator, University of San FranciscoPaul Park, MD, Principal investigator, Semmes-Murphey ClinicGregory Mundis, MD, Principal investigator, Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CAJuan Uribe, MD, Principal investigator, Barrow Neurological Institute, Phoenix, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885244
- Sponsor's protocol ID
- 2138
- Acronym
- MIS
- Status last verified
- Feb 2026
- First submitted
- 10 May 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)
- ClinicalTrials.gov ID
- NCT04885244
- Acronym / sponsor ID
- MIS / 2138
- Conditions
- Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance
- Keywords
- Scoliosis, Kyphosis, Sagittal Imbalance, Spinal Deformity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Spine Study Group FoundationUniversity, hospital or other
- Collaborators
- NuVasive
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Procedure: Index or spine revision surgery for complex adult spinal deformityMulticenter, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients
Key inclusion criteria (17 listed)
- >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)
- One of the following Radiographic criteria:
Key exclusion criteria (6 listed)
- Deformity due to acute trauma
- Active spine tumor or infection
- Patient is unwilling or unable to complete questionnaires
- Women who are pregnant
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Index or spine revision surgery for complex adult spinal deformitySurgical interventions will be patient specified by treating surgeon. | Procedure or surgery | Operative |
Primary outcome
Scoliosis Research Society (SRS) 22r
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Scoliosis specific patient reported outcome
Oswestry Disability Index (ODI)
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Spine specific patient reported outcome
Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive Patient reported outcome
Radiographic Evaluation
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
Visual Analog Scale - Back Pain
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)
Visual Analog Scale - Leg pain
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)
3 secondary outcomes
Edmonton Frail Scale
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Canadian Study of Health and Aging (CSHA)
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Adverse Events
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ray Pinteric contact
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Spinal Deformity and Scoliosis, run by International Spine Study Group Foundation at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Baldus, MS (6184444130, baldusc@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Research Society (SRS) 22r (time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.