Clinical Research Directory

Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis

Lumbar Spinal Stenosis (LSS) is a syndrome characterized by anatomical narrowing of the central canal, lateral recess, or intervertebral foramen of the lumbar spine, leading to compression of nerve roots, the cauda equina, and their associated blood supply. Its clinical manifestations primarily include neurogenic intermittent claudication and/or radiating pain and numbness in the lower extremities. LSS is a common cause of disabling low back and leg pain and neurogenic claudication in middle-aged and older adults. Epidemiological studies confirm that its prevalence increases significantly with age, affecting approximately 11% of the general population and rising to 19.4% among individuals over 60. Against the backdrop of accelerating population aging in China, LSS not only severely threatens the quality of life and physical and mental health of middle-aged and older adults but also imposes a substantial economic burden on society. For patients who do not respond to systematic conservative treatment, surgery can provide rapid relief from low back and leg pain. In recent years, high-quality evidence from randomized controlled trials (RCTs) has shown that in specific LSS subgroups with Grade I lumbar spondylolisthesis, the two-year clinical outcomes of decompression alone are non-inferior to those of decompression with instrumented fusion. This finding suggests that fusion is not an absolute indication for such patients and challenges the potential trend of overuse of fusion in clinical practice, prompting surgeons to more carefully evaluate the risk-benefit ratio of fusion surgery. However, it is important to note that this evidence primarily originates from traditional open surgical approaches and highly selected study populations. Therefore, whether these conclusions can be directly extrapolated to full-endoscopic techniques and their applicability in complex middle-aged and older patient populations with multiple comorbidities remain unclear and warrant further investigation. Against this backdrop, minimally invasive spine surgery technology, guided by the core principle of "achieving maximum efficacy with minimal trauma," has developed rapidly. Over the past decade, full-endoscopic spine techniques, representing the concept of "ultra-minimally invasive" surgery, have made significant progress. This technology, relying on high-definition endoscopic systems, enables precise decompression of neural structures under a magnified and clear surgical field through tiny skin incisions less than 1 cm in diameter and sequentially dilated working channels. Its clinical advantages in reducing perioperative pain and accelerating postoperative recovery have been widely confirmed. Innovations in full-endoscopic techniques have allowed the classic clinical debate of "decompression alone versus decompression with fusion" to be re-examined within a new technological platform. However, high-quality prospective studies directly comparing full-endoscopic decompression alone with Endoscopic Lumbar Interbody Fusion (Endo-LIF) remain scarce, especially evidence specific to the unique patient population of middle-aged and older adults. Consequently, in current real-world clinical practice, a surgeon's choice between these two endoscopic procedures often relies more on personal clinical experience than on support from high-level evidence-based medicine. Based on the aforementioned background, this study aims to conduct a prospective randomized controlled trial comparing the efficacy and safety of full-endoscopic decompression versus endoscopic fusion in middle-aged and older adult patients with LSS, thereby providing a scientific basis for individualized and precise surgical decision-making for this patient population.

Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series

Lumbar spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the lumbar spine. While conservative treatments such as physical therapy and pain management can help some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical approaches, including open laminectomy, have proven effective but carry risks such as extensive muscle damage, considerable blood loss, postoperative spinal instability, and prolonged recovery times. This study evaluates a minimally invasive surgical approach called unilateral laminotomy with bilateral lumbar decompression (ULBLD) using endoscopic uniportal technique as an alternative to traditional methods for patients with lumbar spinal stenosis. The main objective is to assess changes in neurological deficits and disability in patients with lumbar spinal stenosis following this procedure. The study will also document hospitalization duration, surgical time, blood loss, and the incidence of postoperative complications. This multicenter, prospective case series will recruit 78 patients from three medical centers in Mexico. Participants must have symptomatic lumbar spinal stenosis that persists despite at least three months of conservative treatment. Eligible patients will undergo ULBLD using endoscopic uniportal technique, a method that allows precise nerve decompression through a small incision, minimizing damage to surrounding tissues. Standardized clinical assessment tools, including the Japanese Orthopaedic Association (JOA) scale for lumbar disease, Oswestry Disability Index (ODI), and Visual Analog Scale (VAS) for pain, will be used to evaluate outcomes at multiple time points over 12 months. By comparing patients' preoperative and postoperative evaluations, the study aims to determine whether ULBLD using endoscopic uniportal technique effectively improves neurological function and reduces disability while maintaining a favorable safety profile. Findings from this study could lead to a more precise understanding of the impact of ULBLD on disability, pain, and health-related quality of life for patients with lumbar spinal stenosis.

Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Spinal Surgery

The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.

Modified Mini-Open TLIF vs Traditional Open TLIF

This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries. It is designed to answer these main questions: Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better. Participants will: Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery. Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery. During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

Evaluation of a Digital Person-Centered Rehabilitation Program Targeting Physical Activity in Spinal Stenosis Surgery (Get Back)

This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.

Artificial Intelligence Enabled Decision Support for Selection of Patients for Lumbar Spine Surgery

Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice. The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®. The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study. The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case ("patients-like-me"). Finally, the individual prediction and the outcomes for the "patients-like-me" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM. Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.

The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery

This study was planned as a randomized controlled experimental study to determine the effect of progressive muscle relaxation exercises on pain and disability in patients undergoing spinal surgery.

Relief of Lumbar Spinal Stenosis Symptoms

The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis. This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.

Coflex PS3 Actual Conditions for Use Study

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Efficacy of ActiveMatrix on Spinal SSI Rate

This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.