Evaluating & Establishing the Relationship in the Five Critical X-ray Time

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05154825
Study type	Observational
Source	University of California, San Diego
Contact	Pete Chase, MS
Phone	(858) 249-0865
Email	pchase@health.ucsd.edu
Status	Recruiting
Phase
Start date	December 7, 2021
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04968483` - Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
Recruiting	`NCT05038527` - ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery	N/A
Completed	`NCT04691258` - Back Squat Exercise Treatment for Low Back Pain: Clinical Trial	N/A
Recruiting	`NCT05866419` - Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy	N/A
Not yet recruiting	`NCT06367933` - Mini-invasive Spine Surgery for Neuromuscolar Scoliosis	N/A
Completed	`NCT05244031` - Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery	N/A
Completed	`NCT03513757` - Dexmedetomidine and Propofol for Pediatric MRI Sedation	Phase 4
Recruiting	`NCT05391412` - Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery	Phase 4
Recruiting	`NCT05276024` - Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.
Not yet recruiting	`NCT06223737` - Spine Deformity Patients With Optoelectronic Motion Capture	N/A
Recruiting	`NCT04524377` - Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease	N/A
Completed	`NCT02286102` - A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains	N/A
Recruiting	`NCT06144879` - Novel Pedicle Screws Used for Corrective Surgery in Spinal Deformity	N/A
Enrolling by invitation	`NCT04241211` - Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial	Phase 4
Recruiting	`NCT05995327` - Reasons and Risk Factors for Unplanned Spinal Re-operation
Recruiting	`NCT05071144` - Spine Procedures Assisted With RoboTics And Navigation

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms