RecruitingNot Applicable

Complex Adult Deformity Surgery (CADS)

United States, Canada1,500 participantsStarted 2018-07-30

Plain-language summary

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
. Complex patients are defined as and meeting any one of the subsequent criteria:
. Radiographic criteria:
. Procedural criteria:
. Geriatric criteria:

Exclusion criteria

. Age \<18 years of age

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Scoliosis Research Society (SRS) 22r

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

Oswestry Disability Index (ODI)

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

Veterans RAND 12 Item Health Survey (VR-12)

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

Radiographic Evaluation

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

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

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

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

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

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

Trial details

NCT IDNCT04194138

SponsorInternational Spine Study Group Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Christine Baldus, MS

618-444-4130 baldusc@wustl.edu

View on ClinicalTrials.gov More Adult Spinal Deformity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
. Complex patients are defined as and meeting any one of the subsequent criteria:
. Radiographic criteria:
. Procedural criteria:
. Geriatric criteria:

Exclusion criteria

. Age \<18 years of age

What they're measuring

Scoliosis Research Society (SRS) 22r

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

Oswestry Disability Index (ODI)

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

Veterans RAND 12 Item Health Survey (VR-12)

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

Radiographic Evaluation

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

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

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

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

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

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