Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
This is a prospective, single arm, single-center PoC study in adult patients, suffering from a degenerative lumbar (L1-S1) spondylolisthesis, treated by spondylodesis in which NVDX3, an osteogenic implant from human allogeneic origin is used. The screening and implant surgery visits will be used as the reference timepoint respectively for the clinical and the radiological efficacy outcome evaluations. As per standard of care, patients with DLS are followed up to 12 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 24 months post-implant surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
NVDX3 is implanted during a single surgical intervention.
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
Primary Safety Endpoint
Description of all SAEs and NVDX3 related AEs
Time frame: Up to 24 months post implant surgery
Safety: all acute SAEs and NVDX3 related AEs
Description of all acute SAEs and NVDX3 related AEs
Time frame: Between screening (V1) and 6 weeks post-IS (V4)
Safety: all SAEs and NVDX3 related AEs
Description of all SAEs and NVDX3 related AEs
Time frame: Beyond 6 weeks (V4 excluded) until 12 months post-IS
Safety: all SAEs and NVDX3 related AEs
Description of all SAEs and NVDX3 related AEs
Time frame: Beyond 12 months (V7 excluded) until 24 months post-IS
Safety: TEAEs
Description of Treatment Emergent AEs (TEAEs)
Time frame: a. Between screening and week 6 (V4 included) b. Between week 6 (V4 excluded) till month 12 (V7 included) c. Between month 12 (V7 excluded) till month 24 (V9 included) d. Full study duration
Safety: related and unexpected (S)AEs
Description of related and unexpected (S)AEs
Time frame: Between screening (v1) till 24 months post-IS
Safety: AESI
Description of AE of Special Interest (AESI)
Time frame: Between screening (v1) till 24 months post-IS
Safety: Lab data
Description of lab data
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Time frame: Between screening (v1) till 24 months post-IS
Safety: vital signs: physiological parameters
Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure
Time frame: Between screening (v1) till 24 months post-IS
Efficacy: Radiological assessments
Evaluate presence of cortical and trabecular bone formation
Time frame: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Evaluate presence of spinal fusion (Interbody/disc and facet joint fusion status)
Time frame: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Measure the average disc height variations based on CT
Time frame: At Hospital Discharge, 4 and 12 months post-IS
Efficacy: Clinical assessments: investigator questionnaire
Physician rated Clinical Global Impression scale (CGI)
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Patient reported Functional assessments using the ODI
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Patient reported Numeric rating scale (NRS) for pain
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS