ALFA

System
Features
Operative Guidelines • Offers 6 different lengths of
for Articulated Lengthening rail.
Fixation Apparatus (ALFA System) • Variety of clamps to suit
application.
• Offers connector for ring
to connect with Rail to have
hybrid assembly.
• Option of tapered half pins
and HA coated tapered half
pins.

S. H. PITKAR
ORTHOTOOLS PVT. LTD.

Office & Works : Developed with scientific & clinical

EL - 32, " J " Block, MIDC Bhosari, Pune 411 026 India. inputs from various surgeons in India
Tel : 91-20- 40706464, Fax : 91-20- 46768107 & abroad.
Email: [email protected]
www.pitkar.com
ALFA System

Indications

• open and closed fracture fixation

• fractures and disease which generally may result in joint contractures
or loss of range of motion and fractures requiring distraction;
• pseudoarthrosis of long bones;
• limb lengthening;
• Infected fractures or non-unions; and
• correction of long bone deformities.

Implant Components within the ALFA System are for single use only.

The ALFA System does not claim MRI safety or conditionality.

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ALFA System

Precautions :

Neurovascular structures and intra-articular should be avoided.

penetration.

Techniques/Guidelines :

There are several techniques that are the same, irrespective of the
indication treated or construct built using the ALFA System.
These include half pin insertion of the Rail, clamp assembly, and
application of the Distraction/Compression Device.
Each of these will be briefly discussed.

General Half Pin application

Insert the appropriate Drill Guide into a Half Pin hole on the clamp.
Using the ALFA System pin clamp as a guide, Where the Drill Guide
touches the skin, make an incision and push the Drill Guide down to
bone.
Drill the bone through the Drill Guide taking frequent pauses to allow
for heat dissipation. Once the second cortex is perforated stop drilling.
Select appropriate thread length of Tapered half pin. Take care to avoid
plunging the drill bit through the second cortex. Remove the Drill Guide
and insert the Half Pin until bi-cortical purchase is confirmed.

Alternatively, a 1.8mm Drill Tip Wire may be inserted through a 1.8mm

Drill Guide. When proper positioning of the Drill Tip Wire is confirmed, a
cannulated Drill Bit and Drill Guide is used over the Drill Tip Wire.
Remove the Drill Tip Wire, cannulated Drill, and Drill Guide and insert
the Half Pin until bi-cortical purchase is confirmed.

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ALFA System

Assembly :

Following the completion of frame construction, check

and re-tighten all set screws and bolts on the frame to
ensure stability.

Apply proper bandage to build pressure between skin &

bandage.

Preassembly of the ALFA System

The ALFA Rail is available in six lengths;150mm, 200mm,

250mm, 300mm, 350mm, 400mm.
Measurements of each rail are laser marked on rail.

Male end cap Rail Bolt M6 X 7mm Female end cap

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ALFA System

Depending on distance between planned position of

clamps and lengthening required, ALFA Rail is
assembled.

Select the required lengths Rail. Remove the male end

cap of the Rail and join the female end of other Rail in to
it and tighten the Rail bolt 7mm to make the required
length Rail as shown in the picture.

Rail Bolts are available in two Sizes.

M6 canulated & M6 X 7mm which is non canulated.

Male End Part and Female End Part are placed on the exposed proximal and distal
ends of any Rail Segment.

Male End Cap

Female End Cap

Fixation of Clamps on Rail

Clamps are assembled to the rail in their

planned locations. Use 7mm Rail bolts to lock
clamp with the Rail.

Rail Bolt 7mm

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ALFA System

Fixation of Clamps

Clamp options

ALFA Standard 3 Hole Clamps are the standard Clamp

with three pin holes in the same plane of fixation,
17.3mm from the center of the rail.

ALFA Stacked Clamps are available in both

5-hole and 3-hole options. The 5-hole Clamp provides
two planes of fixation, with three pin holes in the lower
level and two pin holes in the upper level. The ALFA
Stacked 3-hole Clamp provides two planes of fixation,
with two pin holes in the lower level and one pin hole
in the upper level.

These Stacked Clamps take the place of having a T-clamp

and are useful in larger anatomy, when dealing with the
bow of the proximal femur, and when using the knee
hinge to span the knee.

Standard 1-hole Clamp offers a single half pin hole and

are useful when space is limited and additional fixation is
required.

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ALFA System

ALFA A-P Angle Attachment Clamp is lower clamp and allow Half Pins to be placed
at varying angles to the rail in the transverse plane.
This lower clamp should be used as static, non-moving
clamp and can be assembled with a variety of upper
clamp including the standard 3-hole Clamp and the
stacked 5-hole Clamp. To avoid impingement with
the rail, place the barrel on the inside of the rail
facing the patient. This clamp is useful in obtaining
out of plane fixation to create a delta configuration.

ALFA stacked 5 Hole, Overhang Clamp can be

assembled with a 2-Hole Clamp and can
be used to place Half Pin very close to the hinge.
When used in knee spanning fixation.

ALFA Compression - Distraction device (CD Unit) :

The CD Unit is attached to the Clamps using two 7mm Rail Bolts. Depending on the
resulting distance between Half Pins, the CD Unit can be attached to the Clamps in a
number of different ways utilizing various holes in the Clamps. A few examples are
shown, including minimum pin spread between the two clamps along with the
remaining thread available for lengthening.

48mm 94mm 32mm

144mm
90mm

90mm

Note that the device should be placed such that the knob can be easily accessed by
the patient or caretaker. Plan the rail length and Clamp positions to best
accommodate the desired distraction or compression goal.

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ALFA System

Use 6mm Allen Key to rotate CD Unit. The central bolt is turned in the counter
clockwise direction to distract. A complete revolution (360°) corresponds to 1mm of
distraction. Each ¼ turn (90°) is laser marked with the numbers 1, 2,
3 or 4 and corresponds to 0.25mm of distraction.

Adjustments if any can be made by pulling the spring loaded

plunger and turning 90° prior to releasing. Rotate an additional
90º to re-engage the plunger, allowing for 0.25mm adjustments.

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ALFA System

Guidelines for Femoral Lengthening

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ALFA System

Select the level of the osteotomy

Select the level of the osteotomy, position of the static and moving clamps, and
overall length of rail based on the desired amount of lengthening.

Insert first Half Pin

The level of the Half Pins depends on the level of the planned osteotomy.
The following steps describe distal femoral lengthening. For distal femoral
lengthening the first pin is placed in the supracondylar region just proximal to
the growth plate in a child or at the level of the adductor tuberoisty in an adult.
The proximal pin is placed at the level of the lesser trochanter.

If proximal femoral lengthning is indicated, place the proximal pin first at the level of
the base of the greater trocanter. The distal pin is placed in the infraisthmal portion
of the femur.

Pre-drill the first Half Pin hole perpendicular to the mechanical axis of the femur
(7° to the shaft or approximately parallel to the knee joint line) using the previously
described Half Pin technique. Insert the first half pin into this hole. This step is
critical in ensuring that the Rail is parallel to the mechanical axis such that
lengthening can occur along the mechanical axis.
Femoral lengthening

Mechanical Axis

90°

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ALFA System

Apply Rail with Clamps

Using ALFA A-P Angle Attachment Clamp, place the
Static Clamp onto the proximal end of the on the rail
and lock it in place with two 7mm Rail Bolts on the
side of the ALFA rail facing away from the patient.
Place the Moving Clamp distal to the static clamp on
the rail construct.
Slide the moving clamp over the first Half Pin.

Use the Rail and Clamps as a guide for inserting

the remaining Half Pins. The second Half Pin
should be inserted in the proximal, static clamp
in a symmetrical position to the first Half Pin. For
example, if the first Half Pin was placed in the most
distal hole of the Moving Clamp, the second Half
Pin should be placed in the most proximal hole in
the Static Clamp and vice versa. This technique
will secure the fixator in a parallel line to the
mechanical axis of the bone. Use the remaining
Clamp holes as guides for Half Pin placement.

The rail can now be removed and the femur

osteotomized between the upper and lower
Half Pins.

Osteotomy of the femur

Make a small incision at the planned level of the

osteotomy. Drill the osteotomy site with a hole and
drill multiple holes thro this hole in different direction
across medial cortex. Use an appropriate osteotomy
to complete femur osteotomy percutaneously.

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ALFA System

Reassemble the Rail with Set Screws M6 X 7.5mm

Following the osteotomy, reapply the rail to the tapered Half Pins. Fix the clamps to
the Half Pins using M6 X 7.5mm Set Screws.

Apply CD unit

Add one Anterior-Posterior Half Pin to the AP Clamp proximally.

Secure the Half Pin with a Set Screw.
Attach the CD Unit between the Static and Moving Clamps using
7mm Rail Bolts as previously described.
Ideally, the thread of the CD Unit available for lengthening will
run in the same direction as the additional Rail available for
lengthening.
Note that for the construct shown, the CD Unit is placed inside the
two Clamps.

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ALFA System

Femoral lengthening with articulated knee

spanning fixation

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ALFA System

Confirm center of rotation of the

knee (CORK)

By using C-arm imager, internally and externally

rotate the knee until the posterior aspects of the
medial and lateral femoral condyles
are overlapping.

This is the plane of the center of rotation of the

knee (CORK).

In this plane, the CORK is located at the

intersection point of Blumensaat’s line and the
posterior cortex of the femur.

On the AP view, the CORK is perpendicular to the

mechanical axis (usually 3° varus to the knee
joint line).
In children it is difficult to visualize the posterior
aspect of the femoral condyles because they
are not ossified. In such situation, an
arthrogram to outline the posterior condyles. Is
useful in children, the center of rotation of the knee
is at the level of the growth plate, at the intersection
of the growth plate and a line extended from the
posterior cortex of the femur.

Insert center of rotation of the knee

reference wire

Insert 1.8mm Wire into the CORK. Proper placement of the Reference Wire is essential
for parallel insertion of the remaining tapered Half Pins.

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ALFA System

Apply Femoral Rail with Clamps

and Hinge

Attach a Knee Hinge instead of an End Cap

to the distal end of the ALFA rail.

Half Pins Insertion

Drill a hole in the proximal femur parallel to the

Reference Wire. Make sure this hole is located in
the mid-coronal plane of the bone and the pin
is parallel in all planes to the Reference Wire. Insert
a Half Pin with the appropriate thread length into
the drilled hole.
Place the static clamp onto the end of the
preassembled rail and lock it in place with two
7mm Rail Bolts on the side of the ALFA rail
facing away from the patient. Use an ALFA Stacked
5 hole Overhang Clamp to get the distal Half Pins as
close to the hinge as possible.

Alternatively ALFA A-P Angle Attachment Clamp may

be used if there is more space. Place the moving clamp
proximal to the static clamp, on the pre-assembled rail
construct. Mount the rail onto the proximal Half Pin
through the most proximal hole of the proximal moving
clamp. Slide the Cannulated Rail Bolt or Hinge Assembly
over the CORK Reference Wire. Support the weight of
the rail so it does not sag and deflect the CORK
Reference Wire.

The second Half Pin should be inserted in the

distal most hole of the distal clamp.

Use the remaining pin clamp holes as guides for

Half Pin placement.

Osteotomy of the femur

The rail can now be removed and perform femur

osteotomy just proximal to the distal tapered Half
Pins.

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ALFA System

Apply Distal Rail

Attach either a standard size Rail 300mm or 400 mm

and Rail 150mm or 250mm and associated end cap to the distal
side of the hinge. Rail 300mm or 400mm and 150mm can also be
used here in order to obtain more distal fixation on the tibia.

Reapply the Rail and insert

Anterior-Posterior Half Pin

Following the osteotomy, reapply the rail to the Half

Pins. An Anterior-Posterior Half Pin can be placed in
the distal Anterior-Posterior Angle Clamp at this
time. Secure the clamps to the Half Pins using
M6 X 7.5mm Set Screws.

Apply ALFA Arc to the Distal Rail

Select appropriate size ALFA Arc and ensure that the

2-hole Lower Pin Clamp of the arc assembly is secured
with ALFA Rail Bolt M6.
The use of M6 bolts allows the assembly to slide with
knee motion and decreases pressure on the knee joint.
Slide this assembly over the end cap and distal rail
segment towards the knee hinge.

Adjust the position of ALFA Arc by loosening the bolt.

Tighten the bolt to secure the position of the ALFA Arc.

Note that in order to obtain optimal fixation in the

tibia, the Rail to ring connection and ALFA Rotation End
Connector of the ALFA Arc can be moved to any open
hole on the Arc. It can also be removed altogether.

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ALFA System

Apply tibial fixation

Tibial Fixation can be done by using one of two

methods.

Option 1 is using another Rail and clamps

on the antero-medial tibial side.

Option 2 is using block for half pins.

Option 1: ALFA Rail tibial fixation

Fix the Rail to the Arc by using ALFA Rotation End
Connector and Rail Bolt 7mm.
Tighten all bolts after assembly & ensure construct
is rigid & stable check that the bolts will be on the
inside of the rail and facing the patient.
Once the rail is in place, these bolts can be difficult
to access.

Connect ALFA Arc by using ALFA Rotation End Connector and Rail Arc Rotation End
to the Rail Arc adjacent to the anterior or antero-medial face of the tibia using a ALFA
Rail Bolt M6mm x 30mm.
Attach the Rail Arc Rotation End to the proximal end
of the tibial rail construct using 7mm Rail Bolts. Using
the proximal hole of the Clamp construct,
insert a Half Pin. Support the weight of the rail and
test the flexion and extension of the knee joint.

Perform the drop test to determine if the knee

bends without friction. Complete the tibial fixation
using the same technique as the femoral rail.
Remove the Reference Wire.

Apply the CD unit between the static and moving

clamps using 7mm Rail Bolts .

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ALFA System

Option 2: By using block for half pins tibial fixation

Perform fixation of tibia firmly with a minimum of 3

tapered half pins by using block for half pins by
considering the safe zones as described earlier.

Start with the antero-posterior Half Pin in the

sagittal plane. After inserting this first Half Pin, test
the range of motion of the knee. The hinge should
allow 90° of motion. Perform a drop test to check
that there is no friction limiting the motion. If there
is friction then adjust the connections to reduce
the friction. Add two additional Half Pins in the
antero-medial and antero-lateral positions.

Apply the CD unit

between the static and moving clamps using 7mm
ALFA Rail Bolts.

Combined femoral and tibial lengthening with

articulated knee spanning fixation

If lengthening of the tibia is indicated in addition

to lengthening of the femur, then follow the ALFA
Rail Tibia fixation (Option 1) previously discussed.
Ensure that the Rail length assembled for the
tibia will be sufficient to support two clamps
and achieve the desired lengthening.

Tibia and fibula osteotomy

Perform Osteotomy of Tibia and fibula considering
safe zones as described earlier.
Use a similar technique to that for the femur to perform
osteotomy of tibia just distal to the proximal half pins.
The fibula osteotomy is done percutaneously in the
distal half.

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ALFA System
ALFA Fixator System

ALFA Rotation End Connector ALFA Standard 3 Hole Clamp

Part No. C 271000000 Part No. C 250001000

ALFA Rail Hinge – Female ALFA Stacked 3 Hole Clamp

Part No. C 258000000 Part No. C 252003000

ALFA Standard Clamp - Hinge ALFA Rail End Cap- Female

Connection
Part No. C 256000000
Part No. C 251001000

ALFA Stacked 5 Hole Clamp ALFA Rail Arc Clamp

Part No. C 252002000 Part No. C 253001000

ALFA Rail End Cap - Male ALFA Rail Arc Rotation End

Part No. C 257000000 Part No. C 260000000

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ALFA System

ALFA Arc
ALFA Rail Hinge - Male
Part No. Size
Part No. C 259000000
C 266000090 Small 90°
C 266000120 Medium 120°
C 266000180 Large 180°

ALFA Stacked 5 Hole Overhang

Clamp

Part No. C 252001000

ALFA Rail

Part No. Size mm

C 261000150 150mm
C 261000200 200mm
C 261000250 250mm
ALFA Standard 1 Hole Clamp C 261000300 300mm
C 261000350 350mm
Part No. C 254001000 C 261000400 400mm

ALFA A-P Angle Attachment Clamp

Part No. C 255001000

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ALFA System

Instruments for ALFA Fixator

System

Rail Bolt M6 Cannulated

Part No. Size mm Drill Guides

C 262000000 28mm
C 263000000 38mm Part No. Description
C 513201000 6 X 5 X 40 mm
C 513301000 6 X 5 X 80 mm
C 513001000 6 X 3.2 X 40 mm
ALFA Rail Bolt M6 C 513101000 6 X 3.2 X 80 mm

Part No. Size mm

C 264000000 27mm
C 265000000 30mm
Allen Key 6mm

Part No. Size mm

ALFA Rail Set Screw M6X7.5mm C 531000000 6mm

Part No. C 269000075

ALFA Locking Nut M6X6mm Half Pin Introducer

D Type
Part No. C 267000000
Part No. C 538001000

ALFA Rail Bolt M6X7mm

90° Screw Driver
Part No. C 268000007
Part No. D 511001000

ALFA Compression And A/F 3mm straight screw driver

Distraction Device
Part No. C 577001000
Part No. C 270001000
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ALFA System

Drill bit cannulated Drill Bit

Part No. Description Part No. Description

C 573000000 4.8X1.8X200 mm C 529000000 3.2 X 200 mm L
C 574000000 3.2X1.8X200 mm C 530000000 4.8 X 200 mm L

Guide wire sleeve Container for ALFA fixator

instrument set
Part No. Description
C 575001000 5 X 1.8 X 40 mm Part No. H 980001000
C 576001000 5 X 1.8 X 80 mm

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