BADAL X Technical Details

BADAL X (Bone Anchoring Device for Artificial Limbs) components

  1. Implant (OFI-C, OFI-Y, OTI)
  2. Adapter (DCA)
  3. Connector (HELI, LUCI)
     

Intended use 

BADAL X is intended to provide a fixed support for the connection of an artificial limb to the residual bone after lower limb amputation in persons with serious complaints associated with the use of a conventional socket attached artificial limb. BADAL X is a non-active surgical device designed for long-term implantation inside the human body. It is intended to be used by (orthopaedic-) surgeons with good knowledge of the specific surgical technique, in a standard orthopaedic environment, for skeletally mature subjects that comply to the in- and exclusion criteria. 

BADAL X is preferably installed in a two stage surgical procedure under spinal or general anesthesia. In a first surgery the Implant is installed into the diaphysis of the bone remnant of the lower limb by retrograde approach. The installation of Implant is press-fit to provide a primary stability for osseointegration. The surface of the Implant is either a rough titanium plasma spray or porous mesh/lattice surface to facilitate fast and solid “bone ingrowth” osseointegration. In a second surgery a cutaneous stoma is created and the transcutaneous Adapter component of BADAL X is attached to the Implant with the M6 Locking Screw. In exceptional cases where there is few soft tissue coverage of the residual bone, BADAL X may be installed in a single surgical procedure. After the second stage surgery the HELI or LUCI Connector is attached to the Adapter with a M14 Abutment Screw to allow a quick-attach-and-release connection of BADAL X with an artificial limb. 
 

BADAL X Component

Property

Specifications

Sizes

Implant OFI-C

Curved press fit intramedullary fixation rod for long femur 

Ti6Al4V-ELI (ASTM F3001). Distal part of the stem is Titanium Plasma Spray coated.The distal head is mirror polished and TiNbN coated

8 sizes: 8 diameters (Ø15mm to Ø 22mm) and 140 mm length

Implant OFI-Y

Straight press fit intramedullary fixation rod for short femur  

Ti6Al4V-ELI (ASTM F3001). The stem is provided with 1mm thick porous lattice surface layer and proximally provided with a 125 degrees oblique 10.5mm diameter hole.The distal head is mirror polished and TiNbN coated

56 sizes:  8 diameters (Ø16mm to Ø 23mm) and 7 lengths (80mm to 140mm)

Implant OTI

Straight press fit intramedullary fixation rod with distal droplet-shape for tibia

Ti6Al4V-ELI (ASTM F3001). The stem is provided with 1mm thick porous lattice surface layer. The proximal part has one or two 5.0mm diameter holes.The distal head is mirror polished and TiNbN coated

40 sizes: 8 diameters (Ø16mm to Ø 30 mm) and 5 lengths (60mm to 100mm)

Lag screw

To be used in combination with OFY-Y

Ti6Al4V-ELI (grade 23) ASTM F136. 

 

5 sizes: diameter 10.45mm and 5 lengths (65mm to 85mm)

Transverse screw

To be used in combination with OTI

Ti6Al4V-ELI (grade 23) ASTM F136. 

 

13 sizes: diameter 4.95mm and 13 lengths; (40mm to 100mm)

DCA

Straight cylindrical rod with on both ends two 16/18 morse tapers for transcutaneous adaptation of implant with connector

Ti6Al7Nb. The cylindrical part is mirror polished and TiNbN coated

5 sizes; 1 diameter 18.0mm and 5 lengths; (70mm to 110mm)

M6 Locking screw

Used to fasten Adapter to implant

Ti6Al7Nb

1 size

Connector Heli and Luci

Quick-attach-and-release component to connect Adapter with artificial limb

Ti6Al7Nb

1 size

M14 Abutment screw

Used to fasten Connector to Adapter

Ti6Al7Nb

1 size



Device Design

BADAL X is designed by incremental innovation and clinical testing based on existing and well-established cementless orthopedic implants. The design and metal alloys of all bone anchoring systems for artificial limbs are adopted from existing uncemented press fit hip implants. A bone anchoring system of an artificial limb can be seen as an inverted stem of uncemented press hip implant. The aspect that makes this device unique and incomparable with a hip implant is that it protrudes through the skin. The transcutaneous fixation with possible pin tract complications is responsible for a different risk-benefit profile than hip implants. 

The design of the BADAL X Implants is dictated by the dimensions and anatomy of the intramedullary canal of the femur and tibia. 

The OFI-C femur Implant is slightly curved to match with the physiological curvature of the femur.

The OFI-Y femur implant is straight and has one 125 degrees oblique 10.5mm diameter hole which is used to insert a canulated 10.45mm diameter OFI-Y lag screw in the hip neck to provide extra mechanical stability.

The OTI tibia implant is straight with a distal droplet shape and has one or two 5mm diameter holes for 4.95mm diameter Transverse Screw. The anatomical shape of the implant matches exactly with the cross-sectional droplet shape of the intramedullary space of the tibia.