Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05190055 |
Other study ID # |
10508-J01 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 25, 2015 |
Est. completion date |
February 26, 2023 |
Study information
Verified date |
July 2022 |
Source |
Chi Mei Medical Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis,
scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were
recruited. The follow-up period was 24 months for each participant. The eligible patients for
this study should be above 18 years old with confirmed indication to TLIF through a posterior
approach. Patients with an active infection, symptomatic osteoporosis, immature bone,
pregnancy, active malignancy, and previous radiotherapy at the planned surgical site were
excluded. Informed consent was signed by each participant before recruitment. We strictly
followed the protocols of patient confidentiality and human subjects in the clinical trial
implementation. The patients were blinded to the allocated surgical technique before the
operation and during the follow-up period of two years. On the one hand, the doctor will
assess the patient's physiological function recovery and imaging examinations (such as CT,
MRI or X-ray) before and after the operation to understand the changes in the patient's pain
index and the effect of intervertebral disc fusion after the operation; on the other hand, It
also evaluates the quality of life and the degree of improvement of psychological emotions
through the questionnaires of patients before and after surgery.
Description:
After receiving prophylactic antibiotics according to the local hospital protocol, the
patients were generally anesthetized in a prone position. Paramedian or midline posterior
sections were conducted, exposing the lumber vertebras encompassing the facet joints. The
facet joints were removed, and decompression was performed. The diseased disc nucleus was
then excised before filling in the bone substitutes. For the control group, the bone
substitutes were filled in the disc space manually using a bone grafting funnel. In the case
of device group, a novel filler tube with integrated threaded rod, which can be connected to
a surgical drill, was used for rapid and continuous graft filling (Figure 1). A
polyethyletherketone (PEEK) interbody fusion cage was then placed into the disc space
followed by fixation with pedicle screws. The treatment efficacy was assessed by clinical
analysis based on the visual analogue scale (VAS) for radicular pain and the Oswestry
Disability Index (ODI) questionnaire for low back pain. The VAS back and leg pain scores were
measured preoperatively and postoperatively at 1, 3, 6, 12, and 24 months. The ODI
questionnaires were taken preoperatively and postoperatively at 3, 6, 12, and 24 months. The
bone graft delivery volume and the filling time during the surgery were measured to compare
the efficiency of the two approaches.
The X-ray and computed tomography were performed prior to surgery and at 3-, 6-, 12-, and
24-monthspost-surgery for bone fusion assessment. The degree of bone fusion was classified
into three grades. Grade I was defined as a complete fusion, union case, and grade II and III
was defined as a partial union and a non-union case, respectively. Bone fusion volume was
further determined by three-dimensional reconstruction images using ITK-SNAP software