Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06075966 |
Other study ID # |
INTRA Spine |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
December 31, 2026 |
Study information
Verified date |
November 2023 |
Source |
Qianfoshan Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.