Introduction
Degenerative lumbar spinal stenosis is the most common cause of chronic pain and disability, reducing quality of life, mobility, and function. Surgical treatment is often required in patients suffering of neurological impairment. Decompression (MiD) or decompression and fusion (MiD+F) are the two main techniques used, but the lack of definitive evidence may complicate surgeons’ choice. The aim of our multicentric observational study is to compare the clinical and mechanical outcomes of the two surgical approaches in order to obtain evidence about the most effective surgery with respect to individual patient’s characteristics.
Methods
In this observational comparative study, we plan to recruit 100 adult patients (>18yrs-old) with symptomatic degenerative lumbar stenosis divided in two groups of equal size: 50 MiD + 50 Mid+F. Enrollment takes place from October 2022 until October 2024 at Istituto Ortopedico Rizzoli and Istituto delle Scienze Neurologiche of Bologna. All patients receive surgery according to current best medical practice and to the surgeons’ choice. Clinical (pain, quality of life) and mechanical evaluation (performance, motor control, balance, spinal mobility, specific motor tasks) are compared in patients undergoing MiD or MiD+F. Mechanical evaluation are performed via Inertial Motion Units (IMU) MbientLab METAMOTIONRL wearable sensors. Data are collected before surgery (at baseline) and after surgery (at 1 month and 3 months follow up).
Results
At present, 32 patients have been enrolled (20 males and 12 females), mean age is 60.23 years old. 18 patients received decompression only, for 14 patients stabilization was required. L4-L5 is the most represented surgical localization of treated stenosis. Most of the patients have been treated at a single level. No major complications have been detected in neither of the groups. Follow up rate at 1 month is currently 75%, 85% at 3 months. 1 patient was lost at follow up. Preliminary analysis on range of motion, static posture and walking tests show a general improvement of outcomes between T0 and T90 for patients treated with MiD; less consistent results are available for MiD+F group. Small sample size affects current analysis and more reliable and robust evidence will be available as the enrollment goes on.
Discussion
This study may provide currently unavailable objective parameters to guide the selection of surgical approach for patients affected by lumbar spinal stenosis. The analysis of motion obtained pre and postoperatively could help the surgeon to better understand how to tailor the surgical treatment on patient-specific characteristics, expectations and needs.