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

NCT ID: NCT05154825

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-07

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Spine Spine Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spine Surgery Participants

Spine surgical candidates that will be receiving posterior only surgery for spinal deformity

Imaging-Observational

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Joseph Osorio

Assistant Professor of Neurological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Osorio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pete Chase, MS

Role: CONTACT

Phone: (858) 657-7651

Email: [email protected]

Facility Contacts

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Pete Chase, MS

Role: primary

Joseph Osorio, MD, PhD

Role: backup

References

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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. 2020 Feb 1;18(2):209-216. doi: 10.1093/ons/opz106.

Reference Type BACKGROUND
PMID: 31214712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30122396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29624129 (View on PubMed)

Other Identifiers

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210830

Identifier Type: -

Identifier Source: org_study_id