An interventional study of Full-Endoscopic Decompression and Endoscopic Lumbar Interbody Fusion in Spinal Stenosis Lumbar, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 176 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Full-Endoscopic Decompression
Procedure: Endoscopic Lumbar Interbody Fusion
Standard full-endoscopic decompression (with a choice of interlaminar or transforaminal approach); performed solely for the purpose of thorough neural decompression, with no implantation of any internal fixation or fusion devices.
Standard Endo-LIF; while completing decompression, an interbody fusion cage (Cage) and a percutaneous pedicle screw system must be implanted to achieve segmental fusion.
Oswestry disability index
0 to 100; Higher scores indicate more severe disability; The ODI is a 10-item questionnaire assessing limitations in daily activities related to low back pain.
Time frame: Baseline (pre-surgery), and 1, 2 years post-surgery.
Numeric Rating Scales
0 to 10; Higher scores indicate more severe pain; Patients are asked to rate the average pain experienced during the past week, where 0 represents "no pain" and 10 represents "worst pain imaginable".
Time frame: Baseline (pre-surgery), and at 1, 3, 6 months, and 1, 2 years post-surgery.
EuroQol 5-Dimension Questionnaire
-0.59 to 1.0 (for the 5L version) / -0.59 to 1.0 (for the 3L version); Higher scores indicate better health-related quality of life; The EQ-5D-5L comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (EQ-VAS). The index score is calculated based on country-specific value sets.
Time frame: Baseline (pre-surgery), and at 1, 3, 6 months, and 1, 2 years post-surgery.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →