Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Motor Deficits, Lumbar Discectomy, Muscle Weakness, Paresis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Muscle Strength [Time frame: Perioperative]
- Duration of paresis before surgical treatment [Time frame: Baseline]
Secondary outcome measures (8)
- Age [Time frame: Baseline]
- Obesity [Time frame: Baseline]
- Diabetes Melitus [Time frame: Baseline]
- Hernia location [Time frame: Baseline]
- Hernia morphology [Time frame: Baseline]
- Level of Pain [Time frame: Perioperative]
- Functionality [Time frame: Perioperative]
- Quality of life assessment [Time frame: Perioperative]
Eligibility criteria
Inclusion criteria
- Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
- Age (years) > 17
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 3 centers
- General Hospital of Kavala — Kavala
- Hippokration General Hospital — Thessaloniki
- European Interbalkan Medical Center — Thessaloniki
Identifiers
NCT: NCT07413302 · 292/2024