The assessment of bone graft vitality and ingrowth in posterior lumbar fusion (PLIF) using 18F-PET-CT scan.

The assessment of bone graft vitality and ingrowth in posterior lumbar fusion (PLIF) using 18F-PET-CT scan. - PLIF using 18F-PET-CT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39166

Enrollment

Registered

2011-08-01

Start date

2011-10-03

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lumbar spondylolisthesis shift vertebrae

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
(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

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results