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

NCT ID: NCT06075966

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Retrospective analysis of patients admitted to the Department of Orthopedic and Spinal Surgery of our hospital who underwent the INTRA Spine dynamic stabilization system and lumbar fusion technology for the treatment of lumbar degenerative diseases. General, clinical, and imaging data were collected before and 7 days, 6 months, and 12 months after surgery. The general information of the patient includes gender, age, course of disease, conservative treatment time, surgical time, nail/implant placement time, bleeding volume, and length of hospital stay; The clinical treatment effect was evaluated using the visual analogue VAS score for low back and leg pain, the Japanese Orthopedic Association's JOA score for evaluation of treatment, and the Oswestry Dysfunction Index questionnaire ODI score; The imaging data includes measuring the lateral position of the surgical segment and adjacent segments through lumbar lateral X-ray films, the Cobb angle, flexion and extension range of motion (ROM), intervertebral disc height, and intervertebral foramen height in the over extension and over flexion positions. The optimal measurement angle value is used, and each measurement data is measured three times and its mean is taken. Perform analysis of variance (intra group follow-up time) and t-test (inter group) on the obtained data using statistical software SPSS; Statistics and analysis of clinical efficacy and imaging manifestations.This clinical study has a funding of 50000 RMB.

Conditions

Lumbar Degenerative Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-fusion group

Intervention Type: OTHER

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.

Fusion group

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Non-fusion group

Intervention Type: OTHER

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.

Fusion group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patient's clinical manifestations, physical examination, and imaging data all support the diagnosis of degenerative lumbar spondylosis
• Those who have undergone strict and formal conservative treatment for at least 3 months before surgery and have no significant improvement in symptoms
• Preoperative imaging examination showed single responsible segment protrusion or protrusion leading to segment stenosis
• Surgeries are performed by the same chief surgeon.

Exclusion Criteria

• Lumbar instability, lumbar spondylolisthesis above grade II
• Patients with severe osteoporosis, tuberculosis, or tumors
• Systemic diseases that affect surgical treatment and medication, such as heart disease, liver disease, and kidney disease
• Patients with mental illness, poor compliance, and inability to cooperate in completing follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao-Xuan Zhang, Ph.D/MD

Role: STUDY_CHAIR

Shandong First Medical University

Locations

Hao-Xuan Zhang

Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INTRA Spine

Identifier Type: -

Identifier Source: org_study_id