An interventional study of Non-fusion group and Fusion group in Lumbar Degenerative Disease, sponsored by Qianfoshan Hospital. Enrolling by invitation at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Qianfoshan Hospital · Not applicable, Interventional, and Treatment
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.
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.
Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: Non-fusion group · 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.
Other: Non-fusion group · Other: 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.
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
VAS
The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends marked as "0" and "10" respectively. A score of 0 indicates painlessness, and a score of 10 represents the most severe pain that cannot be tolerated.
Time frame: 2 Years
JOA
The Japanese Orthopaedic Association Scores (JOA) is a neurological function scoring system recommended by the Japanese Orthopaedic Association, which includes four parts: upper limb motor function, lower limb motor function, sensory and bladder function, with a total score of 29 points. The lower the score, the more severe the neurological dysfunction.
Time frame: 2 Years
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
Time frame: 2 Years
ROM,range of motion
range of motion
Time frame: 2 Years
posterior disc height, PDH
posterior disc height
Time frame: 2 years
foraminal height ,FH
foraminal height
Time frame: 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Qianfoshan Hospital