Clinical trial NCT06075966: The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
Official title: The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lumbar Degenerative Disease
Keywords: INTRA Spine system
dynamic stabilization
non-fusion
Lumbar degeneration
Lumbar range of motion
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS
timeFrame: 2 Years
measure: JOA
timeFrame: 2 Years
measure: Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
timeFrame: 2 Years
Secondary outcomes:
measure: ROM,range of motion
timeFrame: 2 Years
measure: posterior disc height, PDH
timeFrame: 2 years
measure: foraminal height ,FH
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Hao-Xuan Zhang
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Hao-Xuan Zhang, Ph.D/MD
role: STUDY_CHAIR
References: