Treatment of chronic bone infection is considered one of the most challenging procedures in orthopaedic surgery. Reduced susceptibility for traditional antibiotic therapy and extensive bone defects usually require multiple surgical interventions .
OSTEOmycin TM makes biological reconstruction of bone defects and effective local treatment of infections feasible with a single surgical intervention.

What is OSTEOmycin TM?

OSTEOmycin TM is highly purified allograft bone, devoid of antigenic constituents and impregnated with high loads of antibiotics. Thus higher local antibiotic concentration and longer lasting antimicrobial activity is achieved, better than with any other method.

How does OSTEOmycin TM work?

OSTEOmycin TM provides two advantageous modes of action.

  • Antibiotics, bound inside the natural scaffold in a reversible way, are released in a controlled manner, following the needs of effective antimicrobial impact: superior initial concentrations are high enough to penetrate remnants of biofilms and eliminate bacteria embedded therein. More moderate concentrations, kept for several weeks, are protecting the site from re-contamination without compromising neo-osteogenesis.
  • The purified scaffold favours ingrowth of blood vessels with addition of new bone. Restoration of original bone stock proceeds faster than with other substitutes.

How is OSTEOmycin TM processed?

Human allografts are cleaned and processed using supercritical carbon dioxide (scCO2) technologies (OSTEOpure TM). The cleaning process is the most gentle, safe and efficient processing method presently available. It removes all lipids and cellular components completely throughout the whole bone matrix, even in structural allografts. Its virus-inactivating effect is validated. Collagen and osteo-inductive proteins are treated with care. Mechanical properties are mainly unmodified.

Which antibiotics are stored in OSTEOmycin TM?

The characteristics of antibiotics advisable for local application are different from those meant for systemic therapy. Among all possible substances two antibiotics have turned out being ideal:

  • Vancomycin, covering most of the grampositive spectrum and
  • Tobramycin, covering the majority of gramnegative pathogens.

Osteomycin therefore is available in two versions:

OSTEOmycin V TM
OSTEOmycin T TM

Both may be used in combination in cases of mixed infections or whenever cultures are inexplicit. Combining both antibiotics shows a synergistic effect.

NEW GENERATION PROCESSED CHIPS AND STRUCTURAL BONE
ALLOGRAFTS IMPREGNATED WITH TOBRAMYCIN

CHIPS, SHAPED FEMORAL HEADS AND BLOCKS

Treatment of chronic bone infection is considered one of the most challenging procedures in orthopaedic surgery. Reduced susceptibility for traditional antibiotic therapy and extensive bone defects make surgical intervention mandatory for a successful outcome.

The  European Cell and Tissue Bank (ECTB/ÖGGV) has therefore developed a new product which makes biological reconstruction of bone defects and effective local treatment or prevention of infections with a single surgical intervention feasible. Human allografts are cleaned and  processed using  modern  technologies. The cleaning process is a gentle, safe and efficient cleaning process throughout the whole bone matrix even for structural allografts. Its virus-inactivating effect is validated. Lipids and cellular components are removed completely. Collagen and osteoinductive proteins are treated with care. Mechanical properties are mainly unmodified. Thus incorporation in the recipient is faster
and more complete. The allografts are impregnated with antibiotics in a special process that leads to a product with slow elution of antibiotics. Thus higher local antibiotic concentration and longer lasting antimicrobial activity is achieved better than with any other method. (16)

The resulting product OSTEOmycin T™ offers not only ultimate safety and quality, it makes debridement, complete dead space management, biological reconstruction of bone defects as well as implantation of endoprostheses in debrided bone in a one stage approach feasible. (17) Thus  stress  for  the  patient, treatment periods and treatment expenses can be reduced distinctively.
INNOVATIVE PROCESSING METHOD FOR INNOVATIVE PRODUCTS

The bone tissue is procured, tested and processed according the EU Directives and Austrian Tissue Law- Österreichisches Gewebesicherheitsgesetz.

The essential characteristic of processing is that supercritical CO2 technology is used, currently the most gentle and effective technology of cleaning bone allografts. CO2 is used under a pressure of 250 bar with a temperature of 50°C which puts it into supercritical state. Supercritical means that CO2 has the characteristics of both a gas and a fluid. In this state CO2  has the ability of high penetration throughout the whole bone matrix combined with high potential to solve lipids and cellular components associated with lipids. (6) Using this technology lipids and bone marrow are removed, while the collagen matrix consisting of collagen and minerals is mainly maintained. Osteoinductive proteins  are  treated with  care. The native composition of the matrix promotes osteocunduction. (8) The virus-inactivating effect of the process has been validated several times. (7) By removing fat and cellular components antigens are removed (12) and immunological reactions are avoided.

The purified matrix is impregnated with high loads of tobramycin, an aminoglycoside with activity against most gramnegative and grampositive bacteria commonly found in bone infection. Due to the proprietary impregnation technique tobramycin is deposited throughout the whole graft, mainly in the lacunae of the spongy matrix. OSTEOmycin T™ elutes tobramycin slowly. Thus higher local antibiotic concentration and longer lasting antimicrobial activity is achieved better than with any other method. Release of the antibiotic is completed after several weeks and such is not likely to create resistances or initiate the formation of small colony variants. Concentrations in the immediate surrounding reach levels between 100 and 1000 times the levels reachable with systemic antibiotic therapy. (16)

WHY TOBRAMYCIN?

Tobramycin is likely to penetrate glycocalices and in high concentrations and shows a strain dependent biofilm activity.(1, 2, 10) Tobramycin shows among the lowest cytotoxic effect of commonly used antibiotics. (11)

INDICATIONS

OSTEOmycin T™ is favourably used as filler after debridement of osseous sites infected with participation of gramnegative bacteria. Indications include osteitis after trauma or surgery, hematogenic osteomyelitis and infected joint replacement. In cases of mixed infections (grampositive and gramnegative) and chronic infections with inexplicit cultures combination with OSTEOmycin V™ is advisable, taking advantage of the synergistic activity of the two antibiotics. (9, 15)

OSTEOmycin T™ is not suitable for treatment of soft tissue infection.

APPLICATION

Radical debridement is a prerequisite for cure in any orthopaedic infection. All unvascularized bone must be removed down to slightly bleeding surfaces. The site should be rinsed thoroughly with saline until all macroscopically visible debris is cleared. Osseous dead space and bony defects are then filled up with OSTEOmycin T™, using mild to moderate impaction forces, depending from the required effect. Mild impaction will result in accelerated incorporation, moderate forces increase primary stability. Insertion of osteosynthetic material or endoprostheses may precede or follow the grafting procedure, according to local circumstances. Drainage preferably should be performed without suction.

ADVANTAGES

  • The validated virus-inactivation grants ultimate safety. (7)
  • Extraction of lipids and cellular components takes place deep into the bone matrix.
  • The collagen matrix consisting of collagen and minerals is mainly maintained and osteoinductive proteins are treated with care.
  • The native composition of the matrix promotes osteocunduction. (8)
  • The mechanical and structural qualities are mainly equal to those of unprocessed bone tissue. (13)
  • Using impaction grafting the primary stability of purified allografts is favourable compared to not purified, fatty transplants. (4, 5)
  • The cleaning process uses only non-toxic solvents.
  • Processed chips, femoral heads and blocks have no immune response of the recipient.
  • Incorporation at the recipient therefore takes place faster and more complete. (3, 8, 14)
  • Due to the special impregnation technique tobramycin is eluted slowly. Higher local antibiotic concentration and longer lasting antimicrobial activity is achieved better than with any other method. (16)
  • Concentrations of tobramycin in the immediate surrounding reach levels between 100 and 1000 times the levels reachable with systemic antibiotic therapy. (16)
  • Release of the antibiotic is completed after several weeks and such is not likely to create resistances or initiate the formation of small colony variants.
  • The allografts are double-packaged in blisters or glas vials and sterilized.
  • Storage takes place under room temperature conditions for up to 3 years.
  • The products are easy to handle and user-friendly shapening saves time in the operating room.

OSTEOmycin T

OSTEOmycin T