Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

Completed

• Conditions: Lumbar Disc Herniation

• Registration Number: NCT05246241
• Lead Sponsor: Ataturk University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-11-01
• Status Verified: 2022-02
• Study Completion: 2022-02-01
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Paraspinal muscle quality	Preoperative 1 month	Simplified 3-tier classification
Annular tear size	Preoperative 1 month	With computer as millimeter
Modic changes	Preoperative 1 month	Modic classification
Disc degeneration grade	Preoperative 1 month	modified Pfirrmann's classification
sacralization or fusion	Preoperative 1 month	MRI findings

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	4, 12, and 24 months after surgery	Oswestry Low Back Pain Disability Questionnaire
Visual Analog Scale	4, 12, and 24 months after surgery	0-10 numerical scale (0=no pain, 10 =the worst pain)
Short Form 36 (SF36)	4, 12, and 24 months after surgery	SF-36 Questionnaire

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey