Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAristotle University Of Thessaloniki

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy

Age (years) > 17

Disqualifiers

Age (years) < 18

Medical history of lumbar spine surgery

Absence of limb paresis

Motor deficit caused by other than disk herniation aetiologies

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Patients with limb paresis due to lumbar disk herniation undergoing microdiskectomy

Trial outcomes

Primary outcomes

1

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).

Time frame
Perioperative
2

Duration of paresis before surgical treatment

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

Time frame
Baseline

Secondary outcomes

1

Age

The age of participant as measured in years

Time frame
Baseline
2

Obesity

Body Mass Index (BMI) measured as the ratio between the mass measured in kilograms over the square of height measured in meters. There will be two groups of patients: a) with obesity and b) without obesity.

Time frame
Baseline
3

Diabetes Melitus

Participant is diagnosed with diabetes melitus (yes/no)

Time frame
Baseline
4

Hernia location

Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Aristotle University Of Thessaloniki

Lead sponsor

Hippocration General Hospital

Collaborator

General Hospital of Kavala

Collaborator

European Interbalkan Medical Center

Collaborator