Degenerative Lumbar Spondylolisthesis, Distal Radius Fractures
Conditions
Brief summary
An study evaluating the long-term safety of all patients previously treated with NVDX3.
Detailed description
An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the core NVDX3 trial). All patients having signed the ICF enter the long term follow-up study.
Interventions
DRUGNVDX3
NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)
Sponsors
PrimeVigilance
Data Investigation Company Europe (DICE)
Novadip Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient being implanted with NVDX3. 2. Previously participated to one of the NVDX3 core clinical trials. 3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years 4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of the NVDX3 implant | Between screening (V0) and 120 months post-core study (V10) | Description of all SAEs, NVDX3 related AEs and AE of special interest |
Countries
Luxembourg
Contacts
Primary ContactDenis Dufrane, MD
Backup ContactDanielle Gérard, MSc
Outcome results
None listed