Project Description

GENTAFIX® 1 & 3

Surgical Bone Cement with Antibiotic

GENTAFIX® 1 is a high viscosity bone cement for manual application.

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

GENTAFIX® 1&3 contain 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

GENTAFIX® 1&3 bone cements with gentamicin are indicated for use as bone cement in arthroplasty procedures of the hip, knee and to fix plastic or metal prosthetic parts to bone.

These bone cements is indicated for prostheses fixation in primary or secondary surgeries as well as to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Hardening

The maximum temperature reached during polymerisation of GENTAFIX® 1&3 cements is well below the requirements of standard ISO 5833, so significantly reducing the risks of bone necrosis.

Physical properties 

The physical properties of GENTAFIX® 1&3 cement largely exceed the requirements of the ISO 5833 Standard, ensuring perfect long-term physical integrity.

Description Reference
Non-sterile bowl and spatula x 10 T060404
VACUUKIT® T060416

References

Description Reference
GENTAFIX 1® 40g T040140G
GENTAFIX 3® 40g T040340G

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.