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

Recruiting

• Conditions: Spine Deformity; Spine
• Interventions: Other: Imaging-Observational

• Registration Number: NCT05154825
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-29
• Study Start: 2021-12-07
• Study First Posted: 2021-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spine Surgery Participants	Imaging-Observational	Spine surgical candidates that will be receiving posterior only surgery for spinal deformity

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States