Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT07413302
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Study Overview
Official Title:
Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.
Detailed Description:
Background: Motor deficits owing to neural compression caused by lumbar disc herniation are a common problem encountered in spine surgery. Microdiscectomy is considered the preferred procedure for the treatment of limb paresis related to a herniated disc. Nevertheless, there is a restricted number of clinical studies in the literature investigating the role of preoperative factors that could influence the postoperative outcome in these patients.
Aim: To investigate the prognostic factors determining the outcome in patients with lower limb paresis caused by a herniated lumbar disc subjected to microdiscektomy.
Study type: Primary clinical research, observational prognostic study. Materials: Patients suffering from a motor deficit due to lumbar disc herniation to undergo lumbar microdiscectomy in three neurosurgical departments.
Protocol: Prospective multicenter study. This research will discover the prognostic value of two primary and five secondary preoperative factors. Primary factors: a) the severity of paresis, b) the duration of paresis. Secondary factors: a) age, b) body mass index, c) diabetes mellitus, d) anatomic location of the herniated disc, e) morphology of the herniated disc.
Outcomes: The key evaluation criterion is the muscle strength of the most severely affected lower limb muscle according to the six-point (0-5) Medical Research Counsil (MRC) Scale for Muscle Strength. After the comparison between the postoperative and preoperative muscle strength, the outcome of paresis will be recorded as: a) full recovery, b) partial recovery or c) no recovery.
Sample size: Forty (40) patients.
Aim: To investigate the prognostic factors determining the outcome in patients with lower limb paresis caused by a herniated lumbar disc subjected to microdiscektomy.
Study type: Primary clinical research, observational prognostic study. Materials: Patients suffering from a motor deficit due to lumbar disc herniation to undergo lumbar microdiscectomy in three neurosurgical departments.
Protocol: Prospective multicenter study. This research will discover the prognostic value of two primary and five secondary preoperative factors. Primary factors: a) the severity of paresis, b) the duration of paresis. Secondary factors: a) age, b) body mass index, c) diabetes mellitus, d) anatomic location of the herniated disc, e) morphology of the herniated disc.
Outcomes: The key evaluation criterion is the muscle strength of the most severely affected lower limb muscle according to the six-point (0-5) Medical Research Counsil (MRC) Scale for Muscle Strength. After the comparison between the postoperative and preoperative muscle strength, the outcome of paresis will be recorded as: a) full recovery, b) partial recovery or c) no recovery.
Sample size: Forty (40) patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: