NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia
Congenital Pseudarthrosis of TibiaA single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free osteogenic graft.
Lumbar Fusion With Porous Versus Non-Porous Cages
Spinal FusionLumbar Fusion3 moreThe objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: Porous titanium cages Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Prospective Post-market Clinical Follow-up Study of the HBS 2 Resorb Mg in Patients With Intra-...
Intraarticular FractureExtraarticular Fracture2 moreThis study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Congenital Pseudarthrosis of TibiaThe study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
SPECT/CT Bone Scan Quantification Surgery
Pseudoarthrosis of BoneThe hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.
Personalized Spine Study Group (PSSG) Registry
Scoliosis; AdolescenceDegenerative Disc Disease6 moreThe primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells...
Tibia or Femur Pseudo-arthrosisSometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.
Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft...
PseudarthrosisSeptic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation. A possible saving situation used by CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic. The aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and CERAMENT® and the quality of life for this patients.
PMCF Neo Pedicle Screw and Cage Systems
Degenerative Disc DiseaseSpondylolisthesis4 moreThe objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis...
NF1Congenital Pseudarthrosis of TibiaThe current study proposes adding BMP-2 (INFUSE), an anabolic agent, at the surgical site of TPA (tibial pseudarthrosis) repair in children with NF1, compared to a control group of patients treated surgically without BMP-2. The following Specific Aims will be addressed: 1) to determine if use of an osteogenic agent (BMP-2) at the time of surgical repair of TPA in NF1 patients will result in improved bone healing; 2) to document safety of BMP-2 in a pediatric NF1 population; and 3) to collect, process, and preserve biologic specimens at the time of surgery for future studies.