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

• ClinicalTrials.gov Identifier: NCT05154825
• Recruitment Status: Recruiting
• First Posted: December 13, 2021
• Last Update Posted: May 12, 2022
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Joseph Osorio, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment
Spine; Spine Deformity	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 Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: December 7, 2021
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: September 30, 2024

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles [ Time Frame: 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
2. Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar Lordosis [ Time Frame: 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 Outcome Measures :

1. Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery [ Time Frame: 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
2. Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery [ Time Frame: 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 Outcome Measures:

1. PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire [ Time Frame: 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.
2. Oswestry Disability Index [ Time Frame: Through Study Completion, an average of 1 year ]
   The Oswestry Disability Index will be given to assess change over time in functional disability
3. SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire) [ Time Frame: 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
4. Visual Analog Scale (VAS) Low Back and/or Leg [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Contacts and Locations

Contacts

Contact: Pete Chase, MS; (858) 249-0865; pchase@health.ucsd.edu

Locations

United States, California

University of California, San Diego; Recruiting

San Diego, California, United States, 92037

Contact: Pete Chase, MS 858-249-0865 pchase@health.ucsd.edu

Principal Investigator: Joseph Osorio, MD, PhD

Sponsors and Collaborators

University of California, San Diego

Investigators

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

More Information

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.

• Responsible Party: Joseph Osorio, Assistant Professor of Neurological Surgery, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05154825
• Other Study ID Numbers: 210830
• First Posted: December 13, 2021
• Last Update Posted: May 12, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Sharing of IPD depends on future relevant collaborations that require IPD to be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Congenital Abnormalities