Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05538416 |
Other study ID # |
UMCG202200129 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 2022 |
Est. completion date |
December 2023 |
Study information
Verified date |
September 2022 |
Source |
University Medical Center Groningen |
Contact |
Diane H. Steenks |
Phone |
050 3617976 |
Email |
d.h.steenks[@]umcg.nl |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
A combined prospective cohort study and retrospective analysis of previously collected data.
Three different techniques for posterior lumbar interbody fusion (PLIF) are compared:
CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed
up to 6 weeks postoperatively.
Description:
A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively
collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of
180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60
retrospective open PLIF patients and 60 retrospective MI-PLIF patients.
The new data will be collected prospectively by means of questionnaires. No biomaterial will
be collected. The included patients will be asked to complete questionnaires before surgery,
2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital
stay, 2 and 6 weeks after surgery.
Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular
leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic
spondylolisthesis with persistent symptoms for more than 3 months.
Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when
using bisphosphonate), active infection or previous infection at the surgical site, active
cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring
fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder,
substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass
index >40).
Main research question: Does the CBT-PLIF provide less low back pain in the short term than
the traditional open PLIF and the MI-PLIF?
Primary outcome measure
- Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery
Secondary Outcomes
- Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery
- Leg pain
- Oswestry Disability Index
- Quality of life (EQ-5D-5L)
- Observed patient recovery
- Other parameters such as complications, surgical parameters (intraoperative blood loss,
duration of surgery), length of stay in hospital and return to work