Spine Ultrasound Image Study of Spondylolisthesis Patient

NCT04426916 | Completed DMC

• 1 other identifier: H-2005-149-1125
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy.

Conditions

Spondylolisthesis

Keywords

optimal angle

Outcome Measures

Primary Outcomes (2)

• The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)

  The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.

  Preanesthesia

• The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)

  The needle insertion angle where the height of LFD is measured the longest in ultrasound image.

  Preanesthesia

Secondary Outcomes (4)

• The height of LFD measured by ultrasound image.

  Preanesthesia

• The depth from skin (needle insertion point) to LFD.

  Preanesthesia

• The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).

  Preanesthesia

• Patients' gender, age, height, weight, BMI, etc.

  Preanesthesia

Study Arms (2)

normal lumbar spine

Patient without spondylolisthesis or significant spinal anatomic deformity. (ex\> severe spondylosis, spinal stenosis, scoliosis, etc..)

spondylolisthesis

Spondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex\> severe spondylosis, spinal stenosis, scoliosis, etc..)

Other: Spondylolisthesis

Interventions

Spondylolisthesis OTHER

Spondylolisthesis at a single level

spondylolisthesis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective orthopedic surgery in SNUH(Seoul national university hospital) with ASA physical status classification system I, II, III.

You may qualify if:

• Adult patients scheduled for elective orthopedic surgery.
• with ASA physical status classification system I, II, III.

You may not qualify if:

• Patients with communication difficulties.
• Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g) fracture)
• Patients with a medical history of spinal surgery.
• Patients with significant spinal anatomical deformity any other than spondylolisthesis. (for spondylolisthesis patients group)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim Y, Yoo S, Park SK, Bae H, Lim YJ, Kim JT. Optimal angle of needle insertion for spinal anesthesia in patients with spondylolisthesis: an ultrasonographic study. BMC Anesthesiol. 2021 Sep 8;21(1):221. doi: 10.1186/s12871-021-01444-0.

  PMID: 34496754 DERIVED

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 23, 2020
• Primary Completion: August 6, 2020
• Study Completion: August 7, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

KR (1)