The primary objective is to assess the vitality and process of ingrowth of autologous bone graft in PLIF during the first postoperative year in order to predict intervertebral bony union. The second objective is to assess clinical outcome measures.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(i) Osteoblastic activity (i.e., vitality) and integrity of the bone graft by
18F-PET-CT scan at 6 weeks and 12 months postoperative. (ii) Intercorporal bony
fusion by (dynamic) plain radiographs (at 6 weeks and 12 months postop, regular
patient care) and a CT-scan (at 12 months postoperative).
Secondary outcome
Improvement in the following clinical outcomes measurements as assessed after 6
weeks and 1 year after surgery in comparison preoperative scores: Oswestry
Disability Index, Short form 36 questionnaire, visual analog scale (VAS) and
quality of life (EQ-5D).
Background summary
If conservative measures fail, symptomatic lumbar spondylolisthesis can be
treated operatively by posterior lumbar interbody fusion (PLIF) to stabilize
the involved vertebral segment. However, in 10 to 20% of cases bony union
between the two vertebrae does not occur, which can result in persisting pain
and disability. At present, non-union can only be determined reliably by
CT-scan no earlier than 1 year postoperatively, when the remodelled bone has
been calcified. It would be of great value for clinical practice if non-union
could be predicted within a few months after surgery to enable proper therapy
adjustment at an early stage.
Study objective
The primary objective is to assess the vitality and process of ingrowth of
autologous bone graft in PLIF during the first postoperative year in order to
predict intervertebral bony union. The second objective is to assess clinical
outcome measures.
Study design
Prospective pilot study
Study burden and risks
For this pilot study patients will be evaluated by 18F-PET-CT, which is
regularly used in standard patient care. Plain radiographs will be taken
according to regular patient care at 6 weeks and 12 months postoperatively. At
1 year follow-up a regular CT-scan will be performed as current gold standard
assessment of bony union.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Age 18-65 years
BMI less than 30 (i.e., non-obese)
Able to speak and write dutch (questionnaires, patient information, informed consent)
Spondylolisthesis L4-L5 or L5-S1, grade I or II
Informed consent agreed
Prepared to adhere to follow-up examinations
Exclusion criteria
Pregnant or trying to conceive
Earlier operative interventions lower lumbar spine
Earlier lumbar spondylodiscitis
Active or recent infection
Active or recent malignancy
Postradiation lumbar region
Inflammatory disease
Deformity
General locomotor disease, e.g. multiple sclerosis, Parkinson disease
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 | NL32881.068.11 |