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Observational Study of X-ray Time Points in Spinal Deformity Realignment

This observational study is looking at how different X-ray images taken at five key times during and after spinal deformity surgery relate to each other. The intervention involves collecting X-rays before, during, and after your surgery, as well as during follow-up appointments for a year. The goal is to understand how these images help surgeons make decisions and how they relate to the final outcome of your surgery. You may be able to join if you are 18-80 years old, need posterior spinal surgery for adult spinal deformity involving more than three levels, and can provide consent. The study will measure changes in your spinal curves (Sagittal Cobb angles and Total Lumbar Lordosis) from before surgery to about six weeks after. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 40 participants. It is not a randomized or blinded study, meaning there's no comparison group and everyone knows what's happening.
What's involved
You would have X-rays taken before surgery (standing and lying down), during surgery (before and after correction), and after surgery (standing). You would also have follow-up X-rays and clinical data collected for a year after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a year after surgery, with X-rays and clinical data collected during follow-up exams.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05154825

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

UNKNOWN
Not specifiedAges 18–80Observational
University of California, San Diego
~40 participants
Updated 2024-12-20 on ClinicalTrials.gov
What's tested:Imaging-Observational

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles
Measured over Baseline through end of Hospital Stay, an average of 6 weeks
+1 more outcome measured

Conditions

Spine
Spine Deformity

Explore related trials

Spinal Deformity

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Joseph Osorio, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Pete Chase, MS
[email protected]
(858) 657-7651
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

1\) Not meeting candidacy for posterior spine surgery

What this trial measures

  • Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb anglesBaseline 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

  • Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar LordosisBaseline 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