Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1).
Conditions
Interventions
Product Name: NVD-001
Product Code: NVD-001
Pharmaceutical Form: Implant
INN or Proposed INN: Autologous osteogenic cells in ECM with DBM
Other descriptive name: NVD-001
Concentration unit: g gram(s)
Sponsors
Novadip Biosciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has understood and accepted to participate in the study according to all study procedures by signing the approved informed consent. • Male or female subjects aged =18 and is skeletally mature (epiphyses closed) at Visit V0a. • Subject has clinically important pain or neurological symptoms at V0a with or without claudication due to symptomatic degenerative spondylolisthesis grade I or II. (Meyerding Classification) • Conservative treatment of disease has failed for at least 3 months since diagnosis. (ISASS 2011) • Subject has a preoperative ODI score >30. • Subject has an indication for spinal fusion of one vertebral segment (L1-S1) due to symptomatic degenerative spondylolisthesis grade I or II diagnosed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and/or dynamic radiography. • Subject is suitable for surgical operation and incorporation of the PEEK cage(s) by transforaminal lumbar interbody fusion (TLIF) or posterior lumbar intervertebral fusion (PLIF) by minimally invasive or open approach in one mobile segment (L1- S1) with bilateral rigid fixation. No posterolateral lumbar fusion (PLF) technique is allowed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: • Subject has known history of hypersensitivity or anaphylactic reaction to PEEK. • Due to medical or other reasons spine fusion cannot be delayed for up to 6 months. • Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification). • Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia. • Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) > 8% (at least 2 values per year for last 2 years) • Subject is underweight, i.e. body mass index (BMI) =18.5 or has a BMI of =40, or =35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes at V0a. • Overt or active local or systemic infection, including latent infection around (area of) the future surgical implant site. • Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated on in this study. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety (local and systemic) of a specific surgical intervention with the use of NVD-001 (AEs, AESI, SAEs) in patients with symptomatic low-grade degenerative spondylolisthesis grade I or II undergoing surgery for spinal fusion of one vertebral segment (L1-S1).;Secondary Objective: • To evaluate the safety (local and systemic) of a commonly used surgical intervention with the use of locally harvested cancellous bone (laminectomy). • To determine the clinical efficacy of one level spinal lumbar interbody fusion with NVD-001 by imaging assessments. • To determine the clinical efficacy of one level spinal lumbar interbody fusion with locally harvested cancellous bone by imaging assessments. • For both groups: - Functional assessment - Pain assessment - Subsequent surgical interventions (revision, removal, reoperation and supplemental fixation) • For both groups: - To record peri- and postoperative blood loss - To record duration of surgery - To record the number of postoperative hospital days stays - To assess Overall Treatment effect evaluation - QoL assessment;Primary end point(s): • Collecting all adverse events for incidence, severity, relatedness, required action and outcome, up to 12 months post-surgery. • Collecting all SAEs, up to 24 months post-surgery. • Collecting Adverse Events of Special Interest (AESI) up to 24 months post-surgery as part of local and systemic toxicity such as o Signs of local toxicity of experimental product will be evaluated on CT and radiographic images by the local radiologist and the principal investigator as well as by the independent radiologist(s) and include: • Trabecular bone resorption • Intravertebral cystic changes • Soft tissue calcification/ossification • Peridiscal soft tissue swelling • Hyperostosis • Tumour growth o Signs of systemic toxicity will be evaluated on chest radiographs and include appearance of calcification/ ossifica | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of fusion will be assessed on CT-Scans at 6, 9, 12 and 24 months post-surgery by qualitative visual analysis called the “bridging trabecular bone scale”. • Evaluation of Non-fusion will be assessed on Dynamic Radiographs at 6, 9, 12 and 18 months post-surgery and considered as non-fusion if at least one of the following signs occurs: translational motion > 3 mm; angular motion > 5°; vacuum phenomenon in operated disc. • Evaluation of bone production will be done on CT images and will be quantified by using specific software at 6, 9, 12 and 24 months post-surgery. • Functional assessment by means of Oswestry Disability Index (ODI) at screening, 1, 6, 9, 12, 18 and 24 months post-surgery • Pain assessment by means of Brief Pain Inventory (BPI) at screening, pre-operation, discharge, 1, 6, 9, 12, 18 and 24 months post-surgery • Overall Treatment Effect scale (OTE) at 1, 6, 9, 12, 18 and 24 months post-implant procedure. • Quality of life assessment by means of questionnaire EuroQoL 5 Dimensions (EQ-5D-5L) at screening, 9, 12, 18 and 24 months post-surgery • Surgical parameters such as duration of surgery, duration of postoperative hospital stay, subsequent surgical interventions (revision, removal, reoperation and supplemental fixation). ;Timepoint(s) of evaluation of this end point: 6, 9, 12, 18 and 24 months post-surgery. | — |
Countries
Belgium, Czech Republic, Poland
Contacts
Public ContactChief Medical Officer
Novadip Biosciences
Outcome results
None listed