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Completed

NCT Number: NCT05246241

Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

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).

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Device

Preoperative magnetic resonance imaging

Primary outcomes

  1. Paraspinal muscle quality

    Time frame: Preoperative 1 month

    Simplified 3-tier classification

  2. Annular tear size

    Time frame: Preoperative 1 month

    With computer as millimeter

  3. Modic changes

    Time frame: Preoperative 1 month

    Modic classification

  4. Disc degeneration grade

    Time frame: Preoperative 1 month

    modified Pfirrmann's classification

  5. sacralization or fusion

    Time frame: Preoperative 1 month

    MRI findings

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 4, 12, and 24 months after surgery

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

  2. Oswestry Disability Index (ODI)

    Time frame: 4, 12, and 24 months after surgery

    Oswestry Low Back Pain Disability Questionnaire

  3. Short Form 36 (SF36)

    Time frame: 4, 12, and 24 months after surgery

    SF-36 Questionnaire

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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