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

University of California San Diego

Status: Enrolling

Conditions: Spine Deformity; Spine

Treatments: Other: Imaging-Observational

Study type: Observational

Funder types: Other

Identifiers

NCT05154825

210830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Spine Surgery Participants

Description:

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

Treatment:

Other: Imaging-Observational