Clinical trial NCT06833099: The Prediction of Recurrence Lumbar Disc Herniation At L5-S1 Level Through Machine Learning Models Based on Endoscopic Discectomy Via the Interlaminar Approach
Official title: The Prediction of Recurrence Lumbar Disc Herniation At L5-S1 Level Through Machine Learning Models Based on Endoscopic Discectomy Via the Interlaminar Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Lumbar Disc Herniation
Keywords: Machine Learning, Ensemble Learning
Lead sponsor: Nantong First People's Hospital
Sponsor class: OTHER
Collaborators: name: Nantong First People's Hospital
First posted: 2025-02-18
Enrollment: 309
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population Description:

The study population consisted of 309 patients who underwent percutaneous endoscopic interlaminar discectomy (PEID) for L5-S1 lumbar disc herniation between January 2020 and June 2024 at Nantong First People's Hospital. All patients had at least 6 months of follow-up post-surgery. The study focused on identifying factors that predict recurrent lumbar disc herniation (rLDH) after the procedure.

Brief summary: What Was the Study About? This study focused on improving the care of patients with a specific type of back problem called lumbar disc herniation at the L5-S1 level. Doctors often treat this condition with a minimally invasive surgery known as percutaneous endoscopic interlaminar discectomy (PEID). However, sometimes the herniation (the damaged disc) can come back after surgery. The goal of this study was to develop computer models that help predict which patients might experience a recurrence of their herniated disc.

Who Participated? The study reviewed the medical records of 309 patients who had undergone the PEID surgery. Out of these, 33 patients experienced a recurrence of their herniation, while 276 patients did not.

What Did the Researchers Do?

Data Collection:

They gathered information from each patient before the surgery, including clinical details (like body weight and any health conditions such as diabetes) and imaging studies (like X-rays, CT scans, or MRIs) that show the condition of the spine.

Identifying Key Risk Factors:

Using a statistical method called LASSO regression, the researchers identified eight important factors that could influence whether the herniation might come back. These included factors such as body mass index (BMI), a measure related to disc height (posterior disc height index), signs of spinal canal narrowing, how long the patient had symptoms before surgery, and other health conditions.

Developing Prediction Models:

They then used several machine learning techniques (advanced computer methods that learn from data) to build prediction models. Two of the best-performing models were based on methods called Random Forest and Extreme Gradient Boosting (XGB).

What Were the Main Findings?

Key Predictors: Higher BMI and changes in the disc (as measured by the posterior disc height index) were found to be the strongest predictors of a herniation coming back after surgery. Other factors, like spinal canal narrowing and longer duration of symptoms before surgery, also played significant roles.

Practical Implication: These models can help doctors identify which patients are at higher risk for recurrence. With this information, they can adjust treatment plans and follow-up care to better manage and potentially reduce the risk of the herniation coming back.

Why Is This Important? For patients and their families, this study offers hope for more personalized and effective treatment plans, reducing the chances of needing additional surgeries in the future. For healthcare providers, the findings provide useful tools to improve decision-making before surgery, ensuring better long-term outcomes for patients with L5-S1 lumbar disc herniation.

In summary, this research uses modern computer methods to predict the risk of recurrent disc herniation after a common minimally invasive back surgery, aiming to enhance patient care and improve surgical outcomes.

Detailed description: Detailed Description

This study aimed to enhance care for patients undergoing a minimally invasive spine surgery known as percutaneous endoscopic interlaminar discectomy (PEID), which is used to treat herniated discs at the L5-S1 level. Recurrent disc herniation-where the disc problem returns after surgery-can lead to additional pain and the need for further treatment. To address this issue, the research team conducted an in-depth review of patient data gathered at a single hospital.

How the Study Was Conducted Researchers collected comprehensive information from 309 patients who had undergone PEID. This information included clinical details (such as age, body mass index, and existing conditions like diabetes) and imaging data (from X-rays, CT scans, and MRIs) that provided insights into the structure and condition of the spine. Rather than relying on a single factor, the study examined a wide range of variables to understand which ones might predict a recurrence of the herniated disc.

Advanced Data Analysis and Prediction Methods To sift through the large amount of collected data, the team used a statistical technique called LASSO regression. This method helped identify the most influential factors from many possible measurements. Eight key factors emerged, including body mass index (BMI) and specific measurements related to the spinal disc's structure.

Building on this foundation, the study employed several machine learning techniques-advanced computer methods that detect patterns in data-to create models capable of predicting the risk of recurrence. Among the various models tested, two (Random Forest and Extreme Gradient Boosting) stood out for their strong performance. These models not only highlighted the significance of factors like BMI and certain spinal measurements but also provided a promising tool for clinicians to assess risk before surgery.

Why This Matters For healthcare providers, having a reliable predictive model means they can better tailor surgical techniques and postoperative care to individual patients. By understanding a patient's risk profile, surgeons can take additional precautions or consider alternative approaches to reduce the chance of recurrence. For patients and their families, this translates into more personalized treatment plans and potentially fewer complications or repeat surgeries in the future.

In Summary This study represents an important step toward personalized medicine in spinal care. By integrating detailed clinical and imaging data with state-of-the-art machine learning techniques, the researchers developed a model that can forecast the likelihood of a recurrent herniated disc after PEID surgery. The insights gained not only improve the understanding of key risk factors but also pave the way for more targeted and effective treatment strategies, ultimately aiming to enhance long-term patient outcomes.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for rLDH: (A) Patients with L5-S1 lumbar disc herniation who underwent single level PEID. (B) Completed comprehensive imaging examinations within one month before surgery.

(C) Postoperative VAS scores decreased by ≥60%, followed by an increase, confirmed by imaging.

(D) No other abnormalities detected in imaging. (E) Minimum follow-up period of 6 months.

Inclusion Criteria for Non-rLDH: (A) Patients with L5-S1 lumbar disc herniation who underwent single-level PEID. (B) Completed comprehensive imaging examinations within one month before surgery. (C) Postoperative VAS scores decreased by ≥60% without recurrence. (D) No other abnormalities detected in imaging. (E) Minimum follow-up period of 6 months.

Exclusion Criteria:

(A) Presence of other pathological conditions causing lower back pain, such as disc infections, spinal tumors, metabolic bone disease, or osteoporosis. (B) History of prior lumbar disc or other spinal surgeries. (C) Poor imaging quality or incomplete examination data. (D) Patients lost to follow-up.

Primary outcomes:
measure: Recurrence of Lumbar Disc Herniation (rLDH) Following Percutaneous Endoscopic Interlaminar Discectomy (PEID) at the L5-S1 Level
timeFrame: The recurrence will be monitored and documented during follow-up visits at least 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
Study officials:
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