Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease (NCT06715345) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease
South Korea48 participantsStarted 2024-03-06
Plain-language summary
This clinical study aims to evaluate the efficacy and safety of NOVOSIS PUTTY for bone fusion in patients requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease.
Who can participate
Age range22 Years – 80 Years
SexALL
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Inclusion Criteria:
* Adult aged ≥ 22 to ≤ 80 years
* Subjects whose skeletal maturation are confirmed by showing the result of Risser stage 5 in Risser classification, the Plain Radiography
* Subjects diagnosed with disc degeneration in the single level (L2-S1) lumbar spine along with spondylolisthesis of Meyerding grade 1 (degree of translocation: 0- \<25%) or 2 (degree of translocation: 25- \<50%) based on the results of radiological examination (CT, MRI, X-ray).
* Subjects with an ODI (Oswestry Disability Index) score of ≥ 35/100 at screening
* Subjects who were treated with non surgical treatment/therapy for at least 3 months, but were judged to have failed treatment by the investigator
* Subjects who are willing to participate in the study, comply with treatment and procedures, and visit the hospital for all observational evaluations
* Subjects who voluntarily signed the informed consent form after hearing the explanation on objectives and methods of this study
Exclusion Criteria:
* Subjects who have a history of medical device application (spinal instrumentation, for example, anterior disc replacement, interspinous device) to the target site or interbody fusion
* Subjects who are considered that the symptoms occurring in the lumbar region are not occurred by disc degeneration
* Subjects with active malignancy
* Subjects with a documented history of drug abuse (e.g., psychotropic drugs including narcotic analgesics and drugs with high dependence such as alcohol) with…