NCT07413302

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 3, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

January 24, 2026

Last Update Submit

February 9, 2026

Conditions

Keywords

microdiscectomylumbar disc herniationmotor deficitlower limb paresisprognostic factors microdiscectomydisc herniation outcome

Outcome Measures

Primary Outcomes (2)

  • Muscle Strength

    The strength of lower main muscles will be assessed and will be rated according to the Medical Research Council Scale for Muscle Strength. The scale takes values between 0 and 5, with 5 being the best possible (healthy).

    Perioperative

  • Duration of paresis before surgical treatment

    Time between the initiation of paresis and surgical treatment measured in days

    Baseline

Secondary Outcomes (8)

  • Age

    Baseline

  • Obesity

    Baseline

  • Diabetes Melitus

    Baseline

  • Hernia location

    Baseline

  • Hernia morphology

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

Patients with limb paresis due to lumbar disk herniation undergoing microdiskectomy

Patients suffering from motor deficit because of lumbar disk herniation scheduled to undergo single-level microdiskectomy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting the three recruitment hospitals, all located in North Greece.

You may qualify if:

  • Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
  • Age (years) \> 17

You may not qualify if:

  • Age (years) \< 18
  • Medical history of lumbar spine surgery
  • Absence of limb paresis
  • Motor deficit caused by other than disk herniation aetiologies
  • Reoperation within 6 months after microdiskectomy
  • Microdiskectomy at more than one level
  • Cauda equina syndrome
  • Peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

General Hospital of Kavala

Kavala, 65500, Greece

RECRUITING

Hippokration General Hospital

Thessaloniki, 54642, Greece

RECRUITING

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

RECRUITING

MeSH Terms

Conditions

Neurologic ManifestationsMuscle WeaknessParesisIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsPathologic ProcessesSpinal DiseasesBone DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Panagiotis Sarlis

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagiotis Sarlis

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 17, 2026

Study Start

July 3, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations