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Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT05246241
Collaborator
(none)
188
Enrollment
1
Location
10.1
Actual Duration (Months)
18.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.

Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).

Condition or Disease Intervention/Treatment Phase
  • Device: magnetic resonance imaging

Study Design

Study Type:
Observational
Actual Enrollment :
188 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Feb 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Paraspinal muscle quality [Preoperative 1 month]

    Simplified 3-tier classification

  2. Annular tear size [Preoperative 1 month]

    With computer as millimeter

  3. Modic changes [Preoperative 1 month]

    Modic classification

  4. Disc degeneration grade [Preoperative 1 month]

    modified Pfirrmann's classification

  5. sacralization or fusion [Preoperative 1 month]

    MRI findings

Secondary Outcome Measures

  1. Visual Analog Scale [4, 12, and 24 months after surgery]

    0-10 numerical scale (0=no pain, 10 =the worst pain)

  2. Oswestry Disability Index (ODI) [4, 12, and 24 months after surgery]

    Oswestry Low Back Pain Disability Questionnaire

  3. Short Form 36 (SF36) [4, 12, and 24 months after surgery]

    SF-36 Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • first operation for a single-level lumbar disk herniation

  • no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity

  • complete data on clinical and radiological parameters

Exclusion Criteria:

  • the operation was for multi-level pathologies

  • recurrent surgery

  • exhibited concurrent spinal pathology

  • was missing or incomplete clinical and radiological data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Yakutiye Turkey

Sponsors and Collaborators

  • Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Kursat Karadag, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05246241
Other Study ID Numbers:
  • ATANEUROSURGERY-1
First Posted:
Feb 18, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intervertebral Disc Displacement
Recurrence
Hernia

Study Results

No Results Posted as of Mar 8, 2022