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 excellent osteointegration, which enables the formation of bridges between the bone and the bone substitute.
6 weeks after implantation BIOCERA-VET showed:
- bridges with host bone indicative of excellent osteointegration
- osteogenesis within, and around the periphery of the bone substitute thanks to its osteoconductive properties.
Postoperative and 6 week follow up radiographs of a tibial tuberosity advancement (TTA) surgery. The tibial osteotomy 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 courtesy of Prof. Balligand DVM, PhD, Dipl. ECVS, Liège University, Belgium.
TESTED ON HUMANS, APPROVED FOR PETS
Orthopedic surgeons have been confidently using the human equivalent of BIOCERA-VET registered and marketed for over 10 years on more then 10,000 patients, ensuring a proven safety track-record(3).
Use of BIOCERA-VET by specialist veterinary surgeons around the globe, in over 100 canine and feline patients, demonstrated an excellent safety profile with no adverse effects reported.
In human orthopaedic surgery, synthetic bone substitutes are used in the majority (50-60%) of procedures requiring grafts, whilst in veterinary orthopaedics, autografts remain the default for bone substitution(5,6).
With BIOCERA-VET you now have the latest 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 tumors or bone cysts. With this technique bone substitute is injected in the affected bone resulting in bone consolidation and pain relief(7, 8).
With the development of a specific osteosarcoma indication for the new generation bone substitute BIOCERA-VET, the technique is now available to veterinary surgeons providing a novel, minimally-invasive and cost-effective management option for dogs suffering with osteosarcoma.
In a recent study(9) the efficacy of BIOCERA-VET has been assessed for carpal and tarsal arthrodesis, and compared to similar cases treated with bone autograft.
- independent and blinded radiological analysis by specialist veterinary orthopaedic surgeons
- BIOCERA-VET (n=13) vs. autologous bone graft (n=16); both groups followed the standard surgical procedure
Comparative analysis at 8 weeks post-implantation showed:
- bone fusion with BIOCERA-VET similar to that induced by 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 pancarpal arthrodesis.
The arrows indicate the presence of BIOCERA-VET at the level of the radiocarpal, intercarpal and carpometacarpal joints. At the 4 week follow-up, one can observe a transition from the radiopaque bone substitute visible in the immediate postoperative image, towards a less radiopaque new bone formation. At 8 weeks, the consolidated joint has progressive remodelling and a reduced quantity of BIOCERA-VET as it is replaced by new bone.
Arthrodesis of the carpal joint using BIOCERA-VET in a 3-year-old Sighthound dog. May 2020. Images at the courtesy of G. Ragetly DVM, DipACVS, DipECVS - Surgery Specialist -CHV Frégis, France
A critical factor for a successful bone grafting and defect repair is mechanical stability.
Studies(6) 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)(6).
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, whilst maintaining its porosity and bone remodeling properties.
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 achieved when the bone defect is well and completely filled(7,8).
THE NEW GENERATION FOR PALLIATIVE CARE OF DOGS WITH OSTEOSARCOMA
Osteosarcoma, a sad diagnosis for pet owner and vet.
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 mainstay of 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 potentially more invasive, expensive and not always effective.
Cementoplasty with BIOCERA-VET provides a palliative treatment, improving the quality of life for the animal suffering from osteosarcoma. Minimally invasive, percutaneous injection of BIOCERA-VET into bone that has been weakened by tumour, reduces the risk of pathologic fracture, relieves pain and improves patient comfort and quality of life.
BIOCERA-VET offers the veterinarian:
- low-trauma, minimally invasive procedure
- short procedural time - rapid post-operative recovery
- reduced analgesic treatment post-op
- limited costs (compared to amputation
BIOCERA-VET osteosarcoma is perfectly suited to cementoplasty providing:
- complete hardening and maximum mechanical strength within 24 hours of injection
- ease of use because of its rapid preparation and ease of injection
- monitoring of percutaneous injection by fluoroscopy and assessment of postoperative radiographs due to its inherent radiopacity
Patient eligibility criteria for the use of BIOCERA-VET osteosarcoma:
- tumor preferably located in an appendicular bone
- well-circumscribed tumor with preserved surrounding cortical bone
- preferably early stage tumors with no lung nor bone metastasis
Practical use of BIOCERA-VET osteosarcoma:
- minimally invasive procedure
- limited post-operative care
- reduced analgesic treatment after cementoplasty