Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

NCT05246241 | Completed

• 1 other identifier: ATANEUROSURGERY-1
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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).

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (5)

• Paraspinal muscle quality

  Simplified 3-tier classification

  Preoperative 1 month

• Annular tear size

  With computer as millimeter

  Preoperative 1 month

• Modic changes

  Modic classification

  Preoperative 1 month

• Disc degeneration grade

  modified Pfirrmann's classification

  Preoperative 1 month

• sacralization or fusion

  MRI findings

  Preoperative 1 month

Secondary Outcomes (3)

• Visual Analog Scale

  4, 12, and 24 months after surgery

• Oswestry Disability Index (ODI)

  4, 12, and 24 months after surgery

• Short Form 36 (SF36)

  4, 12, and 24 months after surgery

Interventions

magnetic resonance imaging DEVICE

Preoperative magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18-75 male and female single-level lumbar disk herniation

You may qualify if:

• 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

You may not qualify if:

• the operation was for multi-level pathologies
• recurrent surgery
• exhibited concurrent spinal pathology
• was missing or incomplete clinical and radiological data

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Related Publications (2)

• Ammerman J, Watters WC, Inzana JA, Carragee G, Groff MW. Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population. Cureus. 2019 May 7;11(5):e4613. doi: 10.7759/cureus.4613.

  PMID: 31312540 BACKGROUND

• Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.

  PMID: 25694267 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: April 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

TU (1)