NATURAL COMPOSITION; HIGH POROSITY
BIOCERA-VET, a synthetic injectable self-hardening calcium-phosphate bone substitute.
BIOCERA-VET is made from tricalcium phosphate (α-TCP) and ortho-phosphate salts that after crystallization give rise to calcium deficient apatite. This is chemically close to the components in natural bone. Therefore, BIOCERA-VET becomes well integrated in the mineral components of the bone matrix, resorbed by osteoclasts and progressively replaced by newly formed bone. BIOCERA-VET has a full range of micro, meso and macropores that makes it over 50% porous. This supports osteoconduction, facilitates cell colonization and biological fluid penetration which promotes bone remodeling and formation.
Calcium-deficient apatite crystals, chemically very close to the mineral component in bone.
50% porosity promotes bone cell colonization and biological fluid penetration.
UNIQUE OSTEOINTEGRATION AND BONE FORMATION
Thanks to its unique features, BIOCERA-VET shows an excellent osteointegration, which enables the formation of bridges between the bone and the bone substitute.
As from 6 weeks after implantation BIOCERA-VET showed
- bridges with host bone traducing an excellent osteointegration
- newly formed bone inside and at the periphery of the bone substitute thanks to osteoconduction
Post-op and 6 weeks follow up radiographs of a tibial tuberosity advancement (TTA) surgery. The aspect of the canine tibia was filled with BIOCERA-VET. Follow up image at 6 weeks indicates the osteointegration of the bone cement, represented by the smooth transition between the cancellous bone, the new bone formation and BIOCERA-VET. Image at the courtesy of Prof. Balligand DVM, PhD, Diplo. ECVS, Liège University, Belgium.
Scanning electron micrography of a transversal section of calcium-deficient apatite crystals implanted in a rabbit femur, twelve weeks after implantation.
Image adapted from Mellier et al. Acta Biomateriala 2017.
TESTED ON HUMANS, APPROVED FOR PETS
Orthopedic surgeons in human medicine have been confidently using the human equivalent of BIOCERA-VET registered and marketed since more than 10 years on more then 10.000 patients, hence leaning on a proven safety track-record.
Current usage of BIOCERA-VET in more than 100 clinical cases in dogs an cats shows an excellent safety profile with no adverse effect reported by European veterinarian orthopedic specialists around the world.
In human orthopedic surgery, non-autograft bone substitutes are used in most (50-60%) bone graft procedures while in veterinarian bone surgery autografts remain the default procedure for bone substitution.
With BIOCERA-VET you now have the last generation of bone substitute at your disposal, preventing unnecessary complications, without compromising on efficacy and making your surgery shorter and more enjoyable. Also in veterinary orthopedics, the patient deserves the highest standard of care!
In human oncology, cementoplasty is commonly used to consolidate bones affected by benign tumors or bone cysts. In this technique bone substitute is injected in the affected bone resulting in bone consolidation and pain relief.
With the development of a specific osteosarcoma presentation of the new generation bone substitute BIOCERA-VET, the technique now also becomes available for veterinary orthopedists, adding a new, cost-effective and mini-invasive option for dogs suffering from osteosarcoma.
In a recent study the efficacy of BIOCERA-VET has been assessed for carpal and tarsal arthrodesis, and compared to similar cases treated with bone autograft.
- independent and blind radiological analysis by qualified veterinarian orthopedic surgeon
- 13 cases with BIOCERA-VET vs. 16 with autologous bone graft, in addition to the standard surgical procedure
Comparative analysis at 8 weeks post-implantation showed:
- a bone fusion with BIOCERA-VET similar to the one induced by bone autograft
- no complications with BIOCERA-VET compared to a 15-30% complication rate with autografts
BIOCERA-VET BONE SURGERY COMPARABLE EFFICACY IN BONE FUSION AND LESS COMPLICATIONS VS AUTOGRAFTS
BIOCERA-VET - Comparative analysis report for arthrodesis indication. Apr 2021 Data-on-file. Collaborating veterinary surgeons Belgium: Dr Bouvy, Dr Flasse, Dr Van Ommen, Dr Stiévenart. France: Dr Ragetly. (a) Independent radiological analysis following bone fusion score, described by Michael et al., 2003 Ree et al. 2016.
Radiocarpal luxation and fracture of distal ulna, treated by an arthrodesis of the carpal joint.
The arrows indicate the presence of BIOCERA-VET at the level of the radiocarpal, intercarpal and carpometacarpal joints. At the 4 weeks follow-up one can observe a transition from the radiopaque bone substitute visible in the post-op image, towards a less radiopaque new bone formation. At 8 weeks, the consolidated joint showed bone remodeling and a reduced amount of BIOCERA-VET is still visible.
Arthrodesis of the carpal joint associated with BIOCERA-VET in dog, 3 years old. May 2020. Images at the courtesy of DVM G. Ragetly, DipACVS, DipECVS - Surgery Specialist -CHV Frégis, France
A critical factor for a successful bone grafting and defect repair is mechanical stability.
Studies performed with BIOCERA-VET on cadaver bone specimens in an opening wedge high tibial osteotomy (owHTO) showed a significant improvement in the mechanical properties with an increased torsional peak to failure and stiffness (compared to the cadaver bone without substitute.
BIOCERA-VET is self-setting and fast-hardening (after 4-8 minutes), reaching its complete and isothermal hardening after 24 hours, thus contributing to the structural stability and improving biomechanics, while keeping its porosity and bone remodeling facilitating properties.
CT-scan of canine tarsal arthrodesis representing the filling with BIOCERA-VET.
BIOCERA-VET becomes - once mixed - a malleable paste, making it possible to fill bone and articular gaps. In this way the bone substitute makes close contact with the adjacent bone, providing mechanical resistance and promoting new bone formation.
BIOCERA-VET is easy to prepare, according to the needs of modern orthopedic surgery: simple, intuitive and fast-hardening (< 8 min.).
REDUCE SURGERY TIME BY 30 TO 45 MINUTES
Surgeries become easier and faster when harvesting of autogenous bone grafts is not needed. Better results are obtained when the bone defect to treat is well and completely filled.
THE NEW GENERATION FOR PALLIATIVE CARE OF DOGS WITH OSTEOSARCOMA
Osteosarcoma, a sad diagnosis for vet and pet owner.
Osteosarcoma is the most common bone cancer in dogs with about 40,000 cases annually in Europe and the United States, it accounts for about 90% of all canine bone cancers. If left untreated, the average survival time of a dog with osteosarcoma is usually no more than 4-5 months.
In the case of appendicular osteosarcoma in dogs, amputation of the primary tumor remains the preferred treatment. However, amputation is not always feasible due to the weight of the dog, the presence of other osteoarticular or neurological diseases and/or owners’ refusal. Other treatment options are expensive, not always effective and/or invasive.
Cementoplasty with BIOCERA-VET provides a palliative treatment increasing the quality of life for the animal suffering from osteosarcoma. The minimally invasive percutaneous injection of BIOCERA-VET into the bone that has been weakened by the tumor reduces the risk of fractures, reliefs pain and gives more comfort to the animal.
BIOCERA-VET offers the orthopedic veterinarian
- low-traumatic, minimally invasive surgical procedure that can be performed in a short operating time
- rapid post-operative recovery
- reduced analgesic treatment post-op
- limited costs (compared to amputation and/or chemotherapy)
BIOCERA-VET Osteosarcoma perfectly suits the cementoplasty procedure providing:
- full hardening and maximum mechanical strength within 24 hours after injection
- ease of use because of its quick preparation and high injectability
- natural radiopacity of BIOCERA-VET allowing to monitor the injection intraoperatively by fluoroscopy or to view it on X-rays at the end of the injection procedure.
Animal eligibility criteria for the use of BIOCERA-VET Osteosarcoma:
- circumscribed tumor and preserved bone corticals
- tumor lesion preferably located on an appendicular bone
- osteosarcoma in a pre-or medium advanced clinical stage
Practical use of BIOCERA-VET Osteosarcoma:
- minimally invasive surgical procedure
- limited post-operative care
- reduced analgesic treatment after cimentoplasty