Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246241
• Other study ID #: ATANEUROSURGERY-1
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation
• Recurrence

Intervention

Device:
• magnetic resonance imaging
Preoperative magnetic resonance imaging

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Yakutiye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paraspinal muscle quality	Simplified 3-tier classification	Preoperative 1 month
Primary	Annular tear size	With computer as millimeter	Preoperative 1 month
Primary	Modic changes	Modic classification	Preoperative 1 month
Primary	Disc degeneration grade	modified Pfirrmann's classification	Preoperative 1 month
Primary	sacralization or fusion	MRI findings	Preoperative 1 month
Secondary	Visual Analog Scale	0-10 numerical scale (0=no pain, 10 =the worst pain)	4, 12, and 24 months after surgery
Secondary	Oswestry Disability Index (ODI)	Oswestry Low Back Pain Disability Questionnaire	4, 12, and 24 months after surgery
Secondary	Short Form 36 (SF36)	SF-36 Questionnaire	4, 12, and 24 months after surgery