SPECT/CT evaluation of early signs of intervertebral fusion after lumbar arthrodesis with a new titanium implant.
Summary description of the study
Lumbar arthrodesis is a surgical procedure that involves permanently fusing one or more painful vertebrae in the lumbar spine together to eliminate their movements and ensure they behave as a single, solid bone. Thus, it can be said that lumbar arthrodesis corresponds to the fusion between several adjacent vertebrae. The main objective of this study is to evaluate the fusion rate achieved using a porous titanium cage (Juliet-TI® - Spineart).
(BASEC)
Intervention under investigation
The 2 SPECT scans will be performed using an optimized radiological dose that will target exclusively the operated region. These scans will allow us to assess the stability of the lumbar region and the intervertebral fusion after surgery.
(BASEC)
Disease under investigation
This study is aimed at adult patients who have reached skeletal maturity and require intervertebral fusion at one or two adjacent levels, located between the lumbar vertebra L2 and the sacral vertebra S1. The study is open to all patients for whom a titanium cage (Juliet-TI® - Spineart) has been considered in the preoperative phase for the treatment of the following conditions: • Symptomatic degenerative disc disease • Spondylolisthesis due to isthmic lysis • Degenerative spondylolisthesis Grade I.
(BASEC)
- Patient with mature skeletal age - Patient treated with JULIET-TI cage at 1 or 2 levels between L2 and S1 - Patient with symptomatic degenerative spinal disease, isthmic spondylolisthesis, or degenerative spondylolisthesis Grade I - Non-smokers or patients who have stopped smoking for at least 3 months (BASEC)
Exclusion criteria
- Patient with previous lumbar surgery between L2-S1 - Patient known for spinal fractures between L2-S1 - Patient with osteoporosis and cancer - Smoker - Spondylolisthesis Grade II or higher - Patient known for metal sensitivity - Patient known for psychiatric disorders - Patient known for neuromuscular or neurovascular diseases - Pregnant patient (not planned for the next 6 months) (BASEC)
Trial sites
Geneva
(BASEC)
Sponsor
Spineart SA
(BASEC)
Contact
Contact Person Switzerland
Dervilla Bermingham
0041225701262
dbermingham@clutterspineart.comSpineart SA
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
06.01.2020
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Evaluation by SPECT CT of early signs of interbody fusion following lumbar arthrodesis using a porous Titanium cage (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available