The assessment of bone graft vitality and ingrowth in posterior lumbar fusion (PLIF) using 18F-PET-CT scan.
Completed
- Conditions
- lumbar spondylolisthesisshift vertebrae10005944
- Registration Number
- NL-OMON39166
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(i) Osteoblastic activity (i.e., vitality) and integrity of the bone graft by<br /><br>18F-PET-CT scan at 6 weeks and 12 months postoperative. (ii) Intercorporal bony<br /><br>fusion by (dynamic) plain radiographs (at 6 weeks and 12 months postop, regular<br /><br>patient care) and a CT-scan (at 12 months postoperative). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Improvement in the following clinical outcomes measurements as assessed after 6<br /><br>weeks and 1 year after surgery in comparison preoperative scores: Oswestry<br /><br>Disability Index, Short form 36 questionnaire, visual analog scale (VAS) and<br /><br>quality of life (EQ-5D).</p><br>