The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
Phase: NA
Conditions: Lumbar Degenerative Disease
Sponsor: Qianfoshan Hospital

The Study of INTRA Spine Non Fusion 
Technique in the Treatment of Lumbar 
Degenerative Disease 
 
 
 
NCT06075966 
 
 
 
 
 
 
 
 
 
 
 
 
2023.01.23 
 
 

Study Design 
Inclusion and Exclusion Criteria 
Inclusion Criteria: Patients exhibiting clinical manifestations, 
physical examination findings, and imaging data consistent with a 
diagnosis of degenerative lumbar spinal disease. All patients 
underwent rigorous and standardized conservative treatment for a 
minimum of three months preoperatively, with no significant 
improvement in symptoms. Preoperative imaging studies indicated 
the presence of protrusion in a single segment or protrusion resulting 
in segmental stenosis. All patients required surgical intervention for 
degenerative disease affecting the L4-5 segments.  
Exclusion Criteria: Presence of lumbar instability or grade II or 
higher 
spondylolisthesis. 
Diagnosis 
of 
severe 
osteoporosis, 
tuberculosis, or tumors. Systemic diseases, such as cardiac, hepatic, 
or renal conditions, that could adversely affect surgical treatment or 
medication administration. Patients with psychiatric disorders, poor 
compliance, or those unable to cooperate with follow-up assessments 
were excluded from the study. 
General demographic characteristics, clinical scores, and 
imaging data were collected for all enrolled patients both 
preoperatively and one year postoperatively.  
Clinical Data 

The patients were categorized into two groups based on the 
surgical approach: the observation group, which received surgery 
utilizing the Intra-Spine dynamic stabilization system, and the control 
group, which underwent spinal fusion surgery. All patients had no 
prior history of lumbar spine surgery, and this study represented their 
first surgical intervention.  
Before the operation, all patients underwent anteroposterior and 
lateral X-rays of the lumbar spine, as well as dynamic X-rays in 
flexion and extension positions, along with lumbar spine CT and MRI 
scans. 
Postoperatively, 
follow-up 
evaluations 
included 
anteroposterior X-rays of the lumbar spine and CT scans at six months 
and one year after the operation. If conditions permitted, some 
patients also underwent MRI scans for further evaluation. Data were 
collected preoperatively, seven days postoperatively, and at six-month 
intervals up to one year postoperatively. 
Clinical Evaluation Method 
The clinical outcomes and patient improvement were assessed 
using the Japanese Orthopaedic Association (JOA) score, the Visual 
Analogue Scale (VAS), and the Oswestry Disability Index (ODI). 
Radiographic Evaluation Method 
Radiographic 
evaluations 
were 
conducted 
through 
measurements obtained from lateral X-rays of the lumbar spine, 

including neutral, over-extension, and over-flexion positions. We 
assessed the surgical gap and Cobb angle for both the operated 
segment and adjacent segments to determine the range of motion 
(ROM). Posterior disc height (PDH) was defined as the vertical 
distance between the lower edge of the upper vertebral body and the 
upper edge of the lower vertebral body, measured in the lateral X-ray 
at the neutral position. Similarly, foraminal height (FH) was defined 
as the vertical distance between the lower margin of the upper 
vertebral pedicle notch and the upper margin of the lower vertebral 
pedicle notch in the lateral X-ray of the upper vertebral body. 
Statistical Analysis 
All data are presented as mean ± standard deviation (SD). 
Statistical analyses were conducted using a one-way analysis of 
variance (ANOVA) to assess differences between baseline 
measurements within the treatment groups. All statistical analyses 
were performed utilizing SPSS software (version 26.0), and 
differences were considered statistically significant at a p-value of less 
than 0.05.