Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spine; Spine Deformity
• Intervention / Treatment: Other: Imaging-Observational

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Pete Chase, MS; Phone Number: (858) 657-7651; Email: pchase@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California, San Diego
      • Contact: Pete Chase, MS; Phone Number: (858)249-0865; Email: pchase@health.ucsd.edu
      • Contact: Joseph Osorio, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spine Surgery Participants; Spine surgical candidates that will be receiving posterior only surgery for spinal deformity	Other: Imaging-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles	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	Baseline through end of Hospital Stay, an average of 6 weeks
Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar Lordosis	Data analysis will involve analysis of the change of measured total lumbar lordosis in the presurgical baseline, intra-operative and post-surgical X-rays	Baseline through end of Hospital Stay, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery	Data analysis will involve analysis of the post-surgical X-rays utilizing the Sagittal Cobb angles measured segmentally	Through study completion, an average of 1 year
Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery	Data analysis will involve analysis of the post-surgical X-rays utilizing the angle for lumbar lordosis	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire	The PROMIS-29 will be given to assess change over time in global physical, mental and social health.	Through study completion, an average of 1 year
Oswestry Disability Index	The Oswestry Disability Index will be given to assess change over time in functional disability	Through Study Completion, an average of 1 year
SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire)	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	Through Study Completion, an average of 1 year
Visual Analog Scale (VAS) Low Back and/or Leg	The Visual Analog Scale (VAS) for Low Back and/or Leg will be given to assess changes in pain level.	Through Study Completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Joseph Osorio, MD, PhD, University of California, San Diego

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 210830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing of IPD depends on future relevant collaborations that require IPD to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No