The purpose of our study is to evaluate modern dual-energy x-ray absorptiometry scan techniques (iDEXA; General Electronics, USA) as an adjunctive diagnostic tool to evaluate the ongoing process of spinal fusion. Changes in bone mineral density (BMD…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean changes in BMD in specific ROI will be evaluated and subsequently be
correlated to one year CT-scan data on
bony fusion.
Secondary outcome
Mean changes in clinical scores (ODI, SF-36, VAS back and leg pain)
radiographic evaluation (X-ray and CT-scan)
Background summary
Instrumented lumbar spine fusions are performed on a regular basis. Frequently
intertransverse bone graft is applied during surgery to facilitate a bony
fusion between two spinal segments. In spite of the fact that bony fusion is
important for long lasting clinical success, still relatively high non-union
rates are reported for spinal fusion procedures. The biological process of bone
graft remodelling leading to eventual fusion is still poorly understood and it
remains extremely difficult to conclude from regular radiographs whether a true
fusion has occurred. There is still demand for a sensitive
diagnostic tool to demonstrate a solid spinal fusion and so far CT scan is the
best available option to evaluate the actual fusion status of a procedure.
CT-scan can not be used on a routine basis to monitor fusion, due to radiation
exposure and costs. Therefore it remains important to explore relatively new
techniques which may help us to predict whether a spinal fusion occurs or not.
These techniques should not be invasive, have low radiation exposure and should
be inexpensive. Modern improvements in DEXA scanning allow us to monitor BMD
changes in well defined ROI, with low radiation. This is why DEXA scanning
might be an interesting tool to study the process of bone remodelling in the
intertransverse fusion area following an instrumented lumbar
fusion.
Study objective
The purpose of our study is to evaluate modern dual-energy x-ray absorptiometry
scan techniques (iDEXA; General Electronics, USA) as an adjunctive diagnostic
tool to evaluate the ongoing process of spinal fusion. Changes in bone mineral
density (BMD) will be assessed prospectively, specifically in the
intertransverse fusion area. BMD changes in this region of interest may appear
to correspond with the process of bone graft remodelling as solid fusion occurs
and thus be
able to predict succesful bony fusion.
Study design
Prospective cohort study.
Study burden and risks
questionnaires 15 min each visit> 5 times> 1 hour 15 min
DEXA-scan 15 minutens each visit > 4 times > 1 hour
X-rays and CT-scan are usuale care> no extra burden or risk
DEXA-scan has a very low radiation burden (o,ooo5 MsV)> not applicable
wagnerlaan 55
6800 TA Arnhem
NL
wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
1. age 18-80 years
2. low back pain and radicular symptoms caused by lumbar instability
3. leg and/or backpain with one of more of the following phenomena:radiculopathy,
sensory deficit, motor weakness, reflex pathology, neurogenic claudication
4. patient has been non-responsive to at least 6 months of non-operative
treatment prior to study enrollment
5. fusion of only one lumbar level in the L-3 to S-1 region is indicated
Exclusion criteria
1. indication for multiple levels fusion based on gross instability
2. severe osteoporotic/osteopenic
3. active spinal and/or systemic infection
4. systemic disease or condition, which would affect ability to participate in the study requirements (i.e. active malignancy)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28493.091.09 |