Project Description

GENTAFIX®3 & 3MV

Surgical Bone Cement with antibiotic

GENTAFIX® 3 is a low viscosity bone cement with an optimum fluidity for an easy application with syringe or injection gun.

GENTAFIX3 MV is a medium viscosity radiopaque and self hardening bone cement specially designed for cementation techniques such as under vacuum.

 GENTAFIX3 & 3MV contains an antibiotic from aminoglycoside family (Gentamicin) well known for its broad spectrum of activity and its efficacy against most of the bacteria responsible of infection in orthopaedic surgery.

It comes in the form of an ampoule of sterile liquid monomer and a sachet of sterile polymer powder.

ADVANTAGES

  •  Mechanical properties above ISO 5833 standard
  • Low exothermicity in situ
  • Low release of monomer
  • Stable fixation of implants
  • Reduced infection
  • Suitable viscosity
  • Long application time
  • Optimal waiting time

GENTAFIX3 & 3MV are indicated for fixation of prosthesis to living bone in arthroplasty procedures or joint reconstruction following trauma, in primary and revision surgeries.

Hardening

The maximum temperature of 68°C reached during the polymerisation of GENTAFIX3 & 3 MV® lies well below that required by the ISO 5833 Standard, thus reducing the danger of bone necrosis.

Physical properties 

The physical properties of GENTAFIX3 & 3 MV® cement largely exceed the requirements of the ISO 5833 Standard, ensuring perfect long-term physical integrity.

In-vitro release rates

GENTAFIX3 & 3 MV® contains 1g of gentamicin base, a quantity optimised to ensure prolonged release over time and thus prevent post-operative infections.  Starting from the hours immediately after the operation, the period in which the risk of infection is greatest, there is a sizeable and rapid release of gentamicin.

Description Reference
Non-sterile bowl and spatula x 10 T060404
Long cannula syringe T060405
Oblong cannula syringe T060402
VACUUKIT® T060416

References

Description Reference
GENTAFIX 3® 40g T040340G
GENTAFIX3® MV 40g T040341G

Certifications

CE 2797
Class: III

Bibliography

Wahlig, H. and E. Dingeldein (1980). « Antibiotics and bone cements. Experimental and clinical long-term observations. » Acta Orthop Scand 51(1): 49-56.
Lindberg, L., R. Onnerfalt, et al. (1991). « The release of gentamicin after total hip replacement using low or high viscosity bone cement. A prospective, randomized study. » Int Orthop 15(4): 305-9.
Jiranek, W. A., A. D. Hanssen, et al. (2006). « Antibiotic-loaded bone cement for infection prophylaxis in total joint replacement. » J Bone Joint Surg Am 88(11): 2487-500.
Block, J. E. and H. A. Stubbs (2005). « Reducing the risk of deep wound infection in primary joint arthroplasty with antibiotic bone cement. » Orthopedics 28(11): 1334-45.