Spine, Spine Deformity
Conditions
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.
Interventions
OTHERImaging-Observational
Preoperative standing and supine, intraoperative pre- and post-correction, and postoperative standing imaging as well as imaging collected during follow-up exams for a year following surgery
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles | Baseline through end of Hospital Stay, an average of 6 weeks | Data analysis will involve analysis of the change of segmentally measured Sagittal Cobbs angles in the presurgical baseline, intra-operative and post-surgical X-rays |
| Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar Lordosis | Baseline through end of Hospital Stay, an average of 6 weeks | Data analysis will involve analysis of the change of measured total lumbar lordosis in the presurgical baseline, intra-operative and post-surgical X-rays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery | Through study completion, an average of 1 year | Data analysis will involve analysis of the post-surgical X-rays utilizing the Sagittal Cobb angles measured segmentally |
| Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery | Through study completion, an average of 1 year | Data analysis will involve analysis of the post-surgical X-rays utilizing the angle for lumbar lordosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire | Through study completion, an average of 1 year | The PROMIS-29 will be given to assess change over time in global physical, mental and social health. |
| Oswestry Disability Index | Through Study Completion, an average of 1 year | The Oswestry Disability Index will be given to assess change over time in functional disability |
| SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire) | Through Study Completion, an average of 1 year | The SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire) will be given to assess change in the health related quality of life specific to spinal deformity |
| Visual Analog Scale (VAS) Low Back and/or Leg | Through Study Completion, an average of 1 year | The Visual Analog Scale (VAS) for Low Back and/or Leg will be given to assess changes in pain level. |
Countries
United States
Contacts
Primary ContactPete Chase, MS
Outcome results
None listed