Integra LifeSciences

Integra
™
su rgic al T echni que
MBA Titanium Subtalar Implant
™
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Integra™
MBA™ Titanium Subtalar Implant
Table of contents
Implant description�������������������������������������������������������������������������������������������������03
The subtalar MBA™ system offers these unique features����������������������������������03
Indications����������������������������������������������������������������������������������������������������������������03
Contraindications����������������������������������������������������������������������������������������������������03
Surgical technique
04
1. Incision and dissection�������������������������������������������������������������������������������������� 04
2. Probe insertion��������������������������������������������������������������������������������������������������� 04
3. Guide pin insertion��������������������������������������������������������������������������������������������� 05
4. Sizer insertion����������������������������������������������������������������������������������������������������� 05
5. Trial implant insertion���������������������������������������������������������������������������������������� 05
6. Intra-operative radiographs����������������������������������������������������������������������������� 05
7. Implantation�������������������������������������������������������������������������������������������������������� 06
8. Guide pin removal and closure������������������������������������������������������������������������� 06
Post-op/Follow-up06
Instructions for use
07
References08
Features08
Component material
2
Surgical technique Integra™ MBA™
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
08
Implant Description
The subtalar MBA™ titanium implant is the original, time-tested metallic arthrodesis implant
for the correction of pediatric pes valgus and adult posterior tibial tendon dysfunction.
The subtalar MBA™ system offers
these unique features
Contraindications
• Barrel-shaped implant provides optimal medial support.
• Vertical calcaneus.
• Uniform implant diameter minimizes lateral discomfort.
• Rigid flatfoot (unreducible).
• Exclusive slotted design helps prevent implant extrusion.
• Rearfoot varus.
• Cannulated, color-coded instrumentation
simplifies surgical procedure.
• Peroneal spasm.
• Ankle joint valgus.
• Excessive ligamentous laxity.
• Degenerative joint disease of the subtalar joint.
Indications
• Severe obesity.
• Pediatric pes valgus.
• Asymptomatic flatfoot condition.
• Adult posterior tibial tendon dysfunction.
• Patients less than 3 years of age.
Pre-op lateral view
Post-op lateral view
Surgical technique Integra™ MBA™
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Post-op ap view
3
Integra™
05-1002
Yellow probe
MBA™ Titanium Subtalar Implant
Surgical Technique
1. Incision and dissection
2. Probe insertion
Make a 1-3 cm incision over the sinus tarsi along the relaxed
skin tension lines (Fig. 1).
• The intermediate dorsal cutaneous nerves
should course superior to the incision.
• The sural nerve should course inferior to the incision.
• Insert the yellow probe instrument through
the sinus tarsi into the sinus canalis
from lateral to medial until tenting is noted
on the medial aspect of the foot (Fig. 3).
• The probe should be positioned perpendicular
to the lateral wall of the calcaneus, angled
slightly posterior and superior.
• Incise the deep fascia.
The anterior lateral edge of the posterior facet of the
calcaneus should be palpable with instrumentation upon
completing the dissection into the tarsal canal (Fig. 2).
• Move the probe in a clockwise and counter
clockwise direction to slightly dilate the tarsal canal.
• Remove the probe.
incision
Fig. 1
Probe instrument
Fig. 2
4
Surgical technique Integra™ MBA™
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
Fig. 3
05-1006
05-1008
05-1009
05-1010
05-1012
Sizers
05-0017
Guide pin
05-1020
3.5 mm hex
45°
3. Guide pin insertion
• Insert the guide pin and make a small incision
medially to allow the guide pin to exit through
the medial aspect of the foot (Fig. 4).
15°
Guide pin
• The distal aspect of the pin should exit the skin just
inferior to the tibialis posterior tendon and anterior
and slightly inferior to the medial malleolus.
0°
Fig. 4
4. Sizer insertion
• Place the cannulated 6 mm sizer over the guide
pin, and insert it through the sinus tarsi into the
sinus canalis from lateral to medial (Fig. 5).
6 mm sizer
• Assess the range of motion of the subtalar joint.
• Continue to insert the remaining sizers
(8, 9, 10, 12 mm) until proper correction is achieved.
• The appropriate size will allow approximately
2-4 degrees of subtalar joint eversion.
Fig. 5
5. Trial implant insertion
• After the appropriate size is
determined, remove the sizer.
3.5 mm hex
Trial
• Insert the corresponding trial implant using the
cannulated 3.5 mm hex insertion tool (Fig. 6).
• Asses the range of motion of the subtalar joint.
• Use intra-operative imaging to evaluate the degree
of correction and placement of the trial implant.
Fig. 6
6. Intra-operative radiographs
• To determine the correct position on AP
(anteroposterior) view, the leading edge of the trial
implant should approach, but not cross,
the longitudinal bisection of the talus (Fig. 7).
• The trailing edge of the implant should be at least
5 mm medial to the lateral wall of the calcaneus.
Guide pin
5 mm
• Examining the lateral view, the trial implant
should be angled posterior, and the implant
should not be sitting on the floor
of the calcaneus.
Longitudinal bisection
of the talus
Fig. 7
Surgical technique Integra™ MBA™
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5
05-1002
Probe instrument
05-1020
Insertion Device
05-0017
Guide Pin 2 mm
7. Implantation
• Once the appropriate sized trial implant and
placement are determined, remove the trial implant.
Insertion tool
• The equivalent size sterile implant is placed
onto the insertion tool over the guide pin
and threaded in a clockwise direction until
clinical correction is noted (Fig. 9).
• Intra-operative imaging is essential to verify proper
positioning of the implant (Refer to Step 6).
Fig. 9
• Once the implant has been properly positioned,
assess the range of motion of the subtalar joint.
• The appropriate size will allow 2-4
degrees of subtalar joint eversion.
8. Guide pin removal and closure
• Remove the guide pin medially when satisfactory
positioning of the MBA™ implant is obtained (Fig. 10).
• Copiously irrigate the area with saline and
reevaluate subtalar joint motion.
• Close the deep tissue, fascia, and
subcutaneous and skin layers.
• Place the foot in a mildly compressive dressing.
Fig. 10
Post-op / Follow-up
• Restrict ambulation for the first 48 hours followed
by protective weight-bearing in a removable,
below-the-knee, walking cast for two weeks.
• Allow a gradual return to activity over
the course of the next month.
• Typically, adjunctive procedures are performed,
so the appropriate post-operative care
should be followed for these procedures.
6
Surgical technique Integra™ MBA™
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
Instruction for Use
Subtalar implant MBA™
1. Description:
The Subtalar MBA System consists of a soft threaded implant, designed to be inserted between the posterior and
middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. It is important that the
instruments and trial implants used are those specifically
designed for this device to ensure accurate insertion.
The Subtalar MBA implant is cylindrical in shape and incorporates a center cannula designed for use with a guide
wire to facilitate proper placement of the implant. An internal
hex-head allows for maximum torque with minimal risk of
stripping. External rounded threads increase ease of insertion, while slotting of the implant absorbs peak shock and
allows fibrous in-growth.
2. Indications:
The Subtalar MBA System is indicated for use in treatment
of the hyperpronated foot and stabilization of the subtalar
joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint
motion while blocking excessive pronation and the resulting
sequela.
--Severely pronated foot
--Walking intemperance
--Calcaneal stance position greater than 5°
--Manually correctable deformities
--Mid-tarsal breech (arch pain)
--Forefoot varus greater than 10°
3. Contraindications:
The Subtalar MBA implant is contraindicated for use in patients with the following conditions:
--Active local infection. (Any evidence of infection)
--Metal sensitivity or allergic reaction to foreign bodies
--Poor or insufficient bone stock
--The presence of any clinical or functional abnormalities
that would preclude the potential of achieving a good
result for the patient
--Other conditions that may place the patient at risk
(Physiologically)
4. Warnings:
For safe and effective use of this implant system, the surgeon should be familiar with the recommended surgical procedure for this device (see the Surgical Protocol, 81-0006).
Improper selection, placement, positioning, or seating of
the implant may result in unusual loading conditions which
could affect the long-term service life of the implant.
In every case, accepted surgical practices should be followed in post-operative care. The patient should be made
aware of the limitations of the subtalar implant and that
physical activity and full weight bearing have been implicated in premature failure of similar devices.
Patient sensitivity to implant materials should be considered
and assessed prior to surgery.
5. Adverse effects:
The following are specific adverse effects, which should
be understood by the surgeon and explained to the patient.
These do not include all adverse effects, which can occur
with surgery in general, but are important considerations
specific to metallic internal stabilization devices. General
surgical risks should be explained to the patient prior to
surgery.
--Infection
--Pain, discomfort, or abnormal sensations due to
presence of the implant
--Metal sensitivity, or allergic reaction to a foreign body
--Migration of the implant, loosening of the implant
--Delayed correction in alignment
--Decrease in bone density due to stress shielding
--Bursitis
6. Implant materials:
The Subtalar MBA implant is manufactured from titanium
alloy (Ti-6Al-4V ELI, ASTM F 136, ISO 5832-3).
7. Packaging and sterility:
All implants have been sterilized with a minimum dose of
2.5 Mrads of gamma irradiation, sterility assurance level 10
(E-6). Prior to use, inspect package for damage which may
compromise sterility. If damaged, the product must be assumed to be non-sterile. If a sterile metal implant package
is opened but the device is not used, it should be resterilized
according to the hospital’s standard practice. The Subtalar
MBA implants and instruments may be steam sterilized using the following process parameters:
Method
Cycle
Temperature
Exposure time
Steam
Gravity
270°F (132°C)
30 Minutes
Steam
Vacuum
270°F (132°C)
4 Minutes
Surgical implants should not be reused. Any implant once
used should be discarded. Even though it may appear undamaged, it may have small defects or internal stress patterns which may lead to failure.
8. Instructions for reprocessing:
The instrument tray and its contents are provided nonsterile and must be sterilized prior to surgery. The following
instructions should be used for cleaning and decontaminating non-sterile product.
All products should be cleaned, decontaminated and sterilized before use. Always immediately clean and decontaminate all devices that have been soiled.
dispose of implants that exhibit surface or configuration
damage.
Contouring or clamping of implants should be avoided if
possible. It is recommended that implants should not be
cut, sharply bent or re-bent, notched, or scratched. These
alterations can produce defects or stresses, which may lead
to failure of the implant.
10. Caution
Federal Law (USA) restricts this device to sale by or on the
order of a physician.
©2007 *Patented. Integra and the wave logo are trademarks of Integra LifeSciences Corporation or its subsidiaries. ©2007 Integra LifeSciences Corporation. All rights
reserved.
82-0003J
Manual Cleaning Procedure:
--Prepare a neutral pH enzymatic detergent. Enzol®, as
per the manufacturer’s recommendation at 1 oz. per
gallon using lukewarm tap water.
--Fully immerse each device in the prepared detergent and
allow them to soak for a minimum of two minutes.
--After soaking the devices, scrub them using a soft bristle
brush and circular strokes to remove any visible soil. Pay
particular attention to all the areas where the soil could
be imbedded (i.e. grooves, crevices, lumens, blind holes.)
Use a syringe to flush lumens and a pipe cleaner to clean
lumens and holes. Perform cleaning under the water
surface to limit aerosolization of the cleaning fluid and soil,
as well as for worker and environmental safety.
--Rinse devices in lukewarm deionized water for a minimum
of one minute to remove any detergent residuals.
--Prepare a neutral pH enzymatic detergent, Enzol®, in a
sonicator as per the manufacturer’s recommendation at
1 oz. per gallon using lukewarm tap water. Fully immerse
the devices in the detergent and sonicate for 10 minutes.
--After sonication, rinse the devices with lukewarm reverse
osmosis/deionized water for one minute.
--Dry the devices using a clean cloth.
Automated Cleaning Procedure:
--Prepare an enzymatic detergent (Klenzyme®) using
lukewarm tap water as per the manufacturer’s
recommendation.
--Fully immerse the devices and allow to soak for a
minimum of two minutes.
--Following the soak time, flush any lumens of the device
using a syringe.
--Rinse the devices under lukewarm running tap water for
a minimum of one minute.
--Place the devices into an automated washer (Steris 444
or equivalent). The washer cycle parameters are:
Phase
Pre-Wash 1
Recirculation Water
Time (Min.)
Temperature
Cold Tap
02:00
Water
Enzyme Wash 01:00
Wash 1
02:00
Rinse 1
05:00
Detergent
NA
KlenHot Tap Water zyme®,
1 oz/gal
Renu60°C
Klenz™ 1/2
oz/gal
Hot Tap Water NA
--Dry the devices with a clean cloth and visually examine
to determine if all adherent visible soil has been removed.
Thermal Disinfection Cycle for Automated Cleaning
Procedure: Thermal disinfection rinse/cycle should be used
at 82.2°C for 1 minute.
9. Product handling:
Store implants unopened in their respective protective packages until use. When removing the implant from its packaging, observe all relevant aseptic instructions. Protect the
prosthesis from contact with objects, which may damage
the surface finish. Inspect each implant prior to use and
Surgical technique Integra™ MBA™
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY
7
Integra™
MBA™ Titanium Subtalar Implant
References
Instrument tray
#
Reference
Instrument tray
Description
#
Implants
Reference
Description
Instruments
05-0106
MBA™ 6 mm Implant
3
05-0016
Guide Pin Insert Holder
05-0108
MBA 8 mm Implant
4
05-0206
Trial 6 mm
05-0109
MBA™ 9 mm Implant
4
05-0208
Trial 8 mm
05-0110
MBA 10 mm Implant
4
05-0209
Trial 9 mm
05-0112
MBA™ 12 mm Implant
4
05-0210
Trial 10 mm
4
05-0212
Trial 12 mm
1
05-1002
Yellow Probe
2
05-1006
6 mm Sizer
2
05-1008
8 mm Sizer
2
05-1009
9 mm Sizer
2
05-1010
10 mm Sizer
2
05-1012
12 mm Sizer
5
05-1020
Insertion Device
™
™
Disposables
05-0017
Guide pin 2 mm
Features
• The Subtalar MBA™
implant system has
the longest history
of successful clinical
outcomes.*
• Barrel-shaped implant
provides optimal
medial support.
• Uniform implant
diameter minimizes
lateral discomfort.
• Slotted design helps
prevent extrusion.
• Simple, minimally-invasive
surgical procedure.
1
* Data available upon request
5
2
4
Component material
3
6
• Subtalar implant:
Titanium alloy.
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English version
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©2011 Integra LifeSciences Corporation. All rights reserved. ILS 08-07-089-02-11
PRODUCTS FOR SALE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory
approval or clearance requirements for sale in such country or region. ▪ Always refer to the appropriate instructions for use
for complete clinical instructions. ▪ Non contractual document. The manufacturer reserves the right, without prior notice,
to modify the products in order to improve their quality. ▪ WARNING: Applicable laws restrict these products to sale by or
on the order of a physician. ▪ Klenzyme, Enzol and Renuklenz are trademarks or registered trademarks of their respective
owners. MBA, Subtalar MBA, Integra and the Integra logo are trademarks of Integra LifeSciences Corporation.