The hard tissue damage is a normal occurrence in the world requiring large amount of substitute materials, medical and surgical interventation with high costs and resulting in loss of human resources and patient pains. The problem of bone substitution has been known and studied for some considerable time, but no completely effective solution found. It concerns the field of reconstructive surgery in orthopaedy, neurosurgery, dentistry and maxillo-facial surgery.
In orthopaedic surgery, the largest market, bone grafts are widely used in hip and knee artroplasty (osteoarthritis, osteoporotic and traumatic fracture, reumatoid arthritis), neoplastic surgery, osteomyelitis (hematogenic, open fracture, metal implants), spine surgery (disc herniation, tumors, spondilo-discitis)
Autograft has the advantages of not being immunogenic and, even more importantly, it is best for inducing new bone formation in the host. The disadvantages of autograft are the limited quantity available and the strength, shape, and form, which cannot precisely duplicate the bone being replaced. They require additional surgery, more pain for the patient, risk of infection, and additional cost for longer time of surgery.
Allografts, on the other hand, are available in quantity, can be strong, and can duplicate the deficit. Allograft bone has certain biologic problems: unfortunately, however, they are immunogenic and are not as osteoinductive as autograft bone and non-union may result. The problems of disease transmission are well documented (HIV, Hepatitis).
To overcome the previous problems synthetic materials with biological, chemical, morphological and mechanical characteristics similar to the bone have received an increased interest. Synthetic Ca/P materials, such as Hydroxyapatite and Tricalcium Phosphate, which are containing Calcium and Phosphorus as chemical elements similar to the natural bone chemistry, are still increasing as bone substitute biomaterials.
The scientific output from the present project is consisting in the availability for the Public Health Service of a bioactive material be used in the production of Medical Devices (Class 2B) in the bone defects due to patological conditions such as traumatic and infiammatory lesions for the reconstruction and substitution of the bone tissues in the orthopaedic, maxillo-facial, odontoiatric, cranial and neuro surgeries. The technological output is consisting in the availability of a bioactive Ca/P material tailored for bioactive coatings with laser processing.
The up to date production technology of the Hydroxyapatite powder at laboratory scale is giving an indication of production costs at the same level of the competing producers with a consequent competitiveness of the product in the market depending mainly from the commercial strategy.