FITBONE

The FITBONE® was developed in partnership with Prof. Baumgart.  The product was launched in 1997.  Since then, this innovative treatment concept has grown into a global success story. The FITBONE TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.  With appropriate preoperative planning, it is possible to make axial and torsional corrections as part of limb lengthening.
Reliability / Quality / Experience: Several thousand implants since 1997.

Manufactured by WITTENSTEIN intens GmbH
Walter-Wittenstein-Strasse 1 – 97999 Igersheim (Germany)
Tel. +49 7931 493-0 – info@wittenstein-intens.com

Distributed by Orthofix
Orthofix declares that the contents are in conformity with the contents established by the Manufacturer of FITBONE.

Benefits to Surgeon

  • Cutting-edge German engineering.
  • Several thousand devices implanted since 1997.
  • No over-reaming necessary.
  • Accurate and controlled limb lengthening achieved with threefold visual and audible control feedback.
  • There is no interference with magnetic instruments or devices.
  • Accidental retraction is not possible.

Benefits to Patient

  • Comfortable lengthening process facilitated with the small, lightweight and silent Control Set.
  • Reliable feedback from the system throughout the lengthening process.
  • Quick reintegration into daily routines.
  • Short hospitalization.
  • Minimal risk of infection.
  • High product safety.
  • Little scarring.
  • “The potential advantages are many: fewer scars, improved aesthetics, better body image and psychological wellbeing, no irritation through pins and wires, reduced pain, uncommon infections, secondary axial deviation avoided, less joint stiffness, higher activity level during lengthening consolidation, faster rehabilitation, less risk of neurovascular compromise due to wire or screw insertion, and improvement in the ability to work during and after treatment.”1

Indications

  • FITBONE is an intramedullary lengthening system for limb lengthening of the femur and tibia.
  • Differences in leg length of 20 mm or more.

Contraindications

  • Patients with any open wounds/areas with poor soft tissue coverage near the implant.
  • Patients with anatomic deformities which prevent the device from fitting.
  • Patients with poor bone quality that would prevent adequate fixation of the device.
  • Patients with compromised capacity for healing.
  • Patients with metal allergies and sensitivities.
  • Patients in which the implant would cross open epiphyseal growth plates.
  • Blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity.
  • Insufficient intramedullary space which would lead to cortical weakening or vascular damage during an implantation.
  • Patients with a body weight of over 100 kg.
  • Differences in leg length of less than 20 mm.
  • Lack of hip head roofing (hip dysplasia) with femoral extensions.
  • Lack of stability in the surrounding joints.
  • No free access for proximal insertion of the intramedullary lengthening nail (e.g., coxa valga).
  • No reliable exclusion of bone infection.
  • Expected non-compliance, mentally ill patient or patient with clouded consciousness.
  • Pregnancy.
  • Other implanted devices, e.g., insulin pump, implanted defibrillator, neurostimulator and cardiac pacemakers.

In addition to the general risks associated to the surgical intervention, the following side effects may occur in some cases despite correct treatment:

  • Slight tingling to severe pain in the affected limb, particularly during and after distraction.
  • Temporary limited mobility of the affected limb.

Footnotes

  1. Hasler CC, Krieg AH. Current concepts of leg lengthening. J Child Orthop. 2012;6:89-104

Instructions For Use