Clinical trial NCT05154825: Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment
Official title: Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment: Preoperative Standing and Supine, Intraoperative Pre- and Post-correction, and Postoperative Standing Films
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine
Spine Deformity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be select from the UCSD Neurological Surgery Spine clinic who are candidates for Posterior Spinal Surgery involving more then 3 levels of posterior column osteotomies

Brief summary: To establish the relationship in the five critical X-ray time points during multilevel posterior column osteotomies (MPCO) spinal deformity realignment in patients with adult spinal deformity and to follow the participants longitudinally to examine any follow-up X-rays and clinical data to compare to the post-operative standing scan and pre-operative data.

Detailed description: Studies in adult spinal deformity (ASD) have found that the presence of sagittal imbalance directly correlates with worsening quality of life. Multilevel posterior column osteotomies (MPCOs) is a technique that can provide correction to adult spinal deformity. MPCOs can be utilized for revision surgery as an alternative to 3-column osteotomies and have the ability to aggregate large amount of lordosis segmentally. The success of the MPCO technique largely depends on radiographs taken during these surgeries to aid the surgeon in establishing the best screw and rod placement and making intraoperative adjustments. Imaging plays a vital role in evaluating hardware positioning and assessing hardware integrity as well as evaluating potential complication. The investigator plans to evaluate and establish the relationship in the five critical X-ray time points (preoperative standing and supine, intraoperative pre- and post-correction, and postoperative standing films) during MPCO spinal deformity realignment and measure pre- to post-operative outcome longitudinally. The investigator will investigate lumbar lordosis and sagittal and coronal alignment at those 5 time points and examine the relationship between pre-op, intra-op, and post-op images to understand impact of the MPCO technique and examine expected outcome to final outcome. Additionally, if the O-Arm 2D long film scanner is utilized during the surgery, the investigator will analyze that film and compare it to the other X-rays taken.

Eligibility criteria: Inclusion Criteria:

* Surgical Candidate for posterior only surgery for adult spinal deformity
* Patients must require deformity correction greater than 3 levels
* Adults Between the ages of 18-80
* Decisional capacity to consent to the study
* Both Primary and revision surgeries will be included

Exclusion Criteria:

* 1) Not meeting candidacy for posterior spine surgery

Primary outcomes:
measure: Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles
timeFrame: Baseline through end of Hospital Stay, an average of 6 weeks
measure: Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar Lordosis
timeFrame: Baseline through end of Hospital Stay, an average of 6 weeks
Secondary outcomes:
measure: Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Oswestry Disability Index
timeFrame: Through Study Completion, an average of 1 year
measure: SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire)
timeFrame: Through Study Completion, an average of 1 year
measure: Visual Analog Scale (VAS) Low Back and/or Leg
timeFrame: Through Study Completion, an average of 1 year
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Joseph Osorio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan AK, Lau D, Osorio JA, Yue JK, Berven SH, Burch S, Hu SS, Mummaneni PV, Deviren V, Ames CP. Asymmetric Pedicle Subtraction Osteotomy for Adult Spinal Deformity with Coronal Imbalance: Complications, Radiographic and Surgical Outcomes. Oper Neurosurg (Hagerstown). 2020 Feb 1;18(2):209-216. doi: 10.1093/ons/opz106.
citation: Scheer JK, Osorio JA, Smith JS, Schwab F, Hart RA, Hostin R, Lafage V, Jain A, Burton DC, Bess S, Ailon T, Protopsaltis TS, Klineberg EO, Shaffrey CI, Ames CP; International Spine Study Group. Development of a Preoperative Predictive Model for Reaching the Oswestry Disability Index Minimal Clinically Important Difference for Adult Spinal Deformity Patients. Spine Deform. 2018 Sep-Oct;6(5):593-599. doi: 10.1016/j.jspd.2018.02.010.
citation: Lau D, Osorio JA, Deviren V, Ames CP. The relationship of older age and perioperative outcomes following thoracolumbar three-column osteotomy for adult spinal deformity: an analysis of 300 consecutive cases. J Neurosurg Spine. 2018 Jun;28(6):593-606. doi: 10.3171/2017.10.SPINE17374. Epub 2018 Apr 6.