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

Summary

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.

Conditions

• Spinal Stenosis Lumbar

Interventions

PROCEDURE

Full-Endoscopic Decompression

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.

PROCEDURE

Endoscopic Lumbar Interbody Fusion

Standard Endo-LIF; while completing decompression, an interbody fusion cage (Cage) and a percutaneous pedicle screw system must be implanted to achieve segmental fusion.

Sponsors & Collaborators

• Xuzhou Central Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Yongxin Ren · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2029-04-01

Completion

2029-12-31