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ENROLLING BY INVITATION
NCT06075966
NA

The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease

Sponsor: Qianfoshan Hospital

View on ClinicalTrials.gov

Summary

Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. At present, conservative treatment is the preferred choice for this type of disease, and surgical treatment is feasible in cases where conservative treatment is ineffective. The main surgical methods include simple laminectomy and nucleus pulposus removal, intervertebral fusion and internal fixation, intervertebral disc replacement, and non fusion surgery. Simple nucleus pulposus removal surgery has drawbacks such as loss of intervertebral height and foramen height, which can affect spinal stability; Intervertebral fusion and internal fixation surgery has the problem of accelerating adjacent segment degeneration; The current therapeutic effect of lumbar disc replacement is not yet clear, and the technology is not yet mature. In response to the shortcomings of the above surgical methods, the advancement of science and technology has driven the development of spinal surgery, and a new surgical concept has emerged - spinal non fusion fixation technology. The INTRA-Spine dynamic stability system between vertebral lamina is one of the non fusion technologies of the spine. The core concept of this technology is to provide dynamic fixation on the basis of sufficient decompression of nerves, with the rotation center located between the vertebral lamina, which is closer to the normal movement center of the lumbar spine. It simulates the normal physiological structure of the lumbar spine with minimal damage and trauma, and maximizes the preservation of surgical segment mobility while maintaining spinal stability, Reducing stress concentration in adjacent segments caused by local fusion, thereby reducing the acceleration of adjacent segment degeneration, theoretically has good clinical and imaging efficacy.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-01-01

Completion Date

2026-12-31

Last Updated

2025-01-29

Healthy Volunteers

No

Interventions

OTHER

Non-fusion group

Patients who have undergone the INTRA-Spine dynamic stabilization system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University.

OTHER

Fusion group

Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University

Locations (2)

Hao-Xuan Zhang

Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China