RecruitingNot Applicable

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

United States500 participantsStarted 2021-07-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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

✓. \>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:
✓. PI-LL ≥ 25 degrees
✓. Thoracolumbar/lumbar scoliosis ≥ 20 degrees
✓. SVA \>10cm

Exclusion criteria

✕. 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)

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

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

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

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

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

Trial details

NCT IDNCT04885244

SponsorInternational Spine Study Group Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2034-12-31

Contact for this trial

Christine Baldus, MS

6184444130 baldusc@wustl.edu

View on ClinicalTrials.gov More Adult Spinal Deformity trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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

✓. \>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:
✓. PI-LL ≥ 25 degrees
✓. Thoracolumbar/lumbar scoliosis ≥ 20 degrees
✓. SVA \>10cm

Exclusion criteria

✕. 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)