A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).
This is a prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion of one vertebral segment (L1-S1). The study consists of a 12-month initialfollow-up period post-surgery and a subsequent 12-month long term follow-up. NVD-001 is an autologous cellular medicinal product obtained by culture of adipose tissue (liposuction) leading to osteogenic cells after ex vivo isolation, expansion and differentiation of pluripotent adipose-tissue stem cells (ASC), and combination with an allogeneic fully demineralised bone matrix into a 3D bone implant. Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1) who sign informed consent and are eligible will be randomised either to the experimental group (surgical intervention for spinal lumbar interbody fusion with NVD-001) or to the control group (commonly used surgical intervention for spinal lumbar interbody fusion (TLIF, PLIF, minimally invasive or open approach) with one or two PEEK cage(s) filled and surrounded by locally harvested autologous cancellous bone (laminectomy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)
Hôpital Erasme - Neurosurgery Department
Brussels, Belgium
Universitair ziekenhuis Brussel - Brussels Health Campus - Department of Orthopaedics and Traumatology
Brussels, Belgium
Saint-Luc University Hospital
Brussels, Belgium
NVD-001 (nocc AEs)
Number of Adverse Events (AEs) severity, relatedness to the product or procedure, required action and outcome, up to 12 months post-surgery
Time frame: 12 months
NVD-001 (npat AEs)
Number of participants presenting Adverse Events (AEs).
Time frame: 12 months
NVD-001 (nocc SAEs)
Number of serious Adverse Events (SAEs), severity, relatedness to the product or procedure, required action and outcome.
Time frame: 24 months
NVD-001 (npatSAEs)
Number of participants presenting Serious Adverse Events (AEs).
Time frame: 24 months
NVD-001 (nocc AESI)
Number of Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.
Time frame: 24 months
NVD-001 (npat AESI)
Number of participants with Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.
Time frame: 24 months
NVD-001 (npat Safety X-rays)
Number of participants with appearance or absence of calcification/ ossification and ectopic bone formation in comparison with preoperative, as determined by chest X-rays.
Time frame: 24 months
NVD-001 (npat Safety Post-Op)
Number of participants with occurrence or absence of surgical intervention-related safety parameters such as infection and peri- and post-operative blood loss volume
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Algemeen Ziekenhuis Monica O.L.V. - Campus Deurne
Deurne, Belgium
Ziekenhuis Oost-Limburg, Campus Sint-Jan
Genk, Belgium
Centre Hosp. Univ. UCL - Namur site Godinne - Service de neurochirurgie
Yvoir, Belgium
Fakultní nemocnice Brno
Brno, Czechia
Fakultní nemocnice v Motole
Prague, Czechia
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Medyczne Angelius Provita
Katowice, Poland
...and 2 more locations
Time frame: 1 month
NVD-001 (LSF)
Lumbar Spine Fusion progression and non-fusion assessed by serial CT-Scans images of lumbar spine post-surgery and lumbar spine static and dynamic radiographic images.
Time frame: 24 months
NVD-001 (ODI)
Functional disability by means of Oswestry Disability Index (ODI).
Time frame: 24 months
NVD-001 (BPI)
Pain by means of Brief Pain Inventory (BPI).
Time frame: 24 months
NVD-001 (OTE)
Overall treatment effect using OTE scale.
Time frame: 24 months
NVD-001 (QoL)
Quality of life (QoL) by means of patient's questionnaire EuroQoL 5 Dimensions post-surgery.
Time frame: 24 months
NVD-001 (timeSurgery)
Surgical duration.
Time frame: 1 day
NVD-001 (stayPostOp)
Duration of postoperative hospital stay.
Time frame: 7 days
NVD-001 (subsequentSurgery)
Description of subsequent surgical interventions (revision, removal, reoperation and supplemental fixation).
Time frame: 24 months