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| Name | Class |
|---|---|
| Hippocration General Hospital | OTHER |
| General Hospital of Kavala | OTHER |
| European Interbalkan Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | The age of participant as measured in years | Baseline |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients visiting the three recruitment hospitals, all located in North Greece.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panagiotis Sarlis | Contact | +302513501449 | psarlis@gapps.auth.gr |
| Name | Affiliation | Role |
|---|---|---|
| Panagiotis Sarlis | Aristotle University Of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Kavala | Recruiting | Kavala | 65500 | Greece |
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| Baseline |
| Diabetes Melitus | Participant is diagnosed with diabetes melitus (yes/no) | Baseline |
| Hernia location | Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal. | Baseline |
| Hernia morphology | Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation. | Baseline |
| Level of Pain | The pain level of participants will be measured using the Numeric Rating Scale for Pain which ranges from 0 (no pain) to 10 (worst pain imaginable). | Perioperative |
| Functionality | The functionality of participants will be measured using the Oswestry Disability Index (ODI) which consists of 10 questions using a 5-level Likert scale with 0 being the best. | Perioperative |
| Quality of life assessment | This outcome will be measured using the EQ-5D-5L questionnaire. It is using 5-Level Likert scale, with 0 being the best. Also, it includes a self-report of health status using a 0 to 100 scale, 100 being best. | Perioperative |
| Hippokration General Hospital | Recruiting | Thessaloniki | 54642 | Greece |
|
| European Interbalkan Medical Center | Recruiting | Thessaloniki | 57001 | Greece |
|
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D018908 | Muscle Weakness |
| D010291 | Paresis |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D010335 | Pathologic Processes |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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