MID & HINDFOOT SOLUTIONS™
Calcaneal fracture plate
SURGICAL TECHNIQUE
Calcaneal fractures are usually caused by a high-velocity impact to the heel. The most common mechanism of injury
is a fall from a height of 2 meters or more, but calcaneal fractures also result from motor vehicle accidents.
Calcaneal fractures may be extra or intra-articular. Surgical treatment with open reduction and internal fixation
(ORIF) is now well accepted to be the method which gives recognized clinical results, especially for type II and type III
calcaneal fractures according to the Sanders classification. The aim of the surgical procedure is to restore the articular
surface of the calcaneus and to obtain an anatomic reconstruction (height and width of the calcaneus).
However, clinical and technical problems can occur due to the thickness and the stiffness of the plates, in particular
superficial necrosis of the surgical wounds and peroneal tendinitis. These problems are related to the traction onto
the skin flap during surgery and to the thickness of the plates that may cause ischemic problems to the skin and
impingement of the peroneal tendons.
Moreover, most plates have a limited number of holes and do not allow for significant moulding because of their
thickness. In this situation, the screws have to be inserted in predetermined sites of the calcaneal wall, and especially
in the fractured zones of the lateral calcaneal wall, in the comminuted fractures. Sometimes this can lead to
insufficient grip of the screws and therefore insufficient mechanical resistance of the implant. In those circumstances,
early movement to prevent joint stiffness and enhance fractured soft tissue healing is not possible.
The CALCANEA® plate is the solution of choice for the ORIF treatment of calcaneal fractures.
This plate is made of titanium alloy (TAl6V4), has an anatomical shape corresponding to the anatomy of the
calcaneus. It is available in three different sizes, to better fit the calcaneus shape (5.5 cm long for size small, 6.5 cm
long for size medium and 7.5 cm long for size large). Its thickness is 1 mm in the middle, and 1.80 mm in the sites
of main fixation. 3-4 holes are present in its anterior, posterior and upper parts for fixation screws with threaded
heads, and 9-10 holes for variable orientation of the screws. The plate is fixed using 3.5 mm screws. Holes in the
plate provide fixation with up to 4 screws in the posterior tuberosity, 3 screws in the anterior process, and 7 screws
in the middle. The limited thickness permits to mould the plate and to eventually cut it if the plate is overstuffing
anatomically the calcaneus. The upper part of the posterior and anterior borders can sometimes be cut off, or bent
for a dorso-plantar screw fixation. Before the definitive fixation of the plate, autologous or synthetic bone grafts
may be inserted, if necessary, in the os trigonum of the calcaneus.
Advantages:
• Increased stability by locking screw fixation and “bridging” of the primary fracture line
• Low profile plate
• Thickness allows remodeling according to the lateral wall of the calcaneus
• Low irritation of soft tissues and tendons
• Reconstruction of height and width of the calcaneus
• Large number of holes for versatile fixation
• Dual screw fixation system (locking & variable) allowing stable fixation regardless of bone conditions
• Angulation of the screws up to 30°
• Bi-cortical or mono-cortical fixation
• Color coded for the plate and the screws
TECHNICAL DESCRIPTION
2 • CALCANEA® • SURGICAL TECHNIQUE
It is always possible to fix the Calcanea® plate in a good cortical area of the lateral calcaneal wall with locking
screws, thus improving the mechanical resistance of the implant. The plate exerts a compression effect when screws
are tightened, reducing the width of the posterior tuberosity. Therefore, it allows the connection of the thalamus
portion to the inferior segment. This improved mechanical resistance may make it possible to reduce the period of
partial weight bearing after the operation.
The Calcanea® plate has been successfully tested* in an experimental calcaneus fracture model on synthetic bone,
showing high stability and low plate deformation when loading.
(* M. Richter MD, PhD, Trauma department Hannover medical school, Germany)
CALCANEA® • SURGICAL TECHNIQUE • 3
SURGICAL TECHNIQUE
AS SUGGESTED BY PROF. THERMANN, M.D., HEIDELBERG, GERMANY
Newdeal® as the manufacturer of this device, does not practice medicine and does not recommend this or any other surgical
technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and
using the appropriate techniques for implanting the device in each patient.
Preoperative planning
The indication for surgery is based on lateral and axial radiographs, tangential Broden views of the
posterior facet. CT scan in the axial and coronal plans is analyzed to evaluate displacement and reduction
strategies.
The Bohler, De Langre and Preiss angles are measured.
1st step: Calcaneal reconstruction
The patient is positioned in a lateral decubitus position. Safe support is needed so that the table can be tilted for
fluoroscopy or for an additional reduction maneuver. The landmarks for incision are the distal fibula, the anterior
process of the calcaneus, the calcaneocuboid joint and the base of the 5th metatarsal. A large L-shaped (right side)
or J-shaped (left side) surgical incision is made beginning approximately 4 cm above the tip of the lateral malleolus,
midway between the posterior border of the fibula and the Achilles tendon.
The lateral incision allows direct access and easier reduction of the displaced
lateral fragment, compared to medial approach. The incision begins
proximally, curves below the sural nerve, and then moves upward to the
calcaneocuboid joint. It is imperative to avoid harming the sural nerve and
prevent skin flap difficulties.
4 • CALCANEA® • SURGICAL TECHNIQUE
The incision is made down to the bone in order to make a
cutaneous - subcutaneous flap that includes the peroneal
tendons. The flap is developed anteriorly to expose the
posterior subtalar joint.
The flap is elevated, along with the sural nerve and peroneal
tendons. Pins are then inserted and bent to hold the flap and
the soft tissues. The subtalar joint is opened and the fractures
of the lateral calcaneal wall are dissected, in order to expose
the fractured and depressed articular fragments.
The reduction maneuver usually begins at the posterior
articular surface and proceeds to the Gissane angle and to the
body of the calcaneus. However, if varus tilt of the calcaneus
prevents anatomic reduction of the posterior facet, the
alignment of the body may need to be corrected prior to the
reduction of the joint surface.
The fractured lateral wall of the calcaneus is gently opened,
leaving the fracture fragments within their periosteal
envelope.
The fragments are elevated, the articular surface is reduced,
and fixation is made using temporary Kirschner wires.
Intraoperative aspect of extended lateral approach
to the fractured calcaneus
1: Calcaneocuboid joint
2: Ankle joint capsule
3: Lateral malleolus
4: Subtalar joint
5: Lateral wall of calcaneus (fractured)
CALCANEA® • SURGICAL TECHNIQUE • 5
2nd step: Calcanea® plate positioning
At this point, the Calcanea® plate is used. The size that best fits the calcaneal anatomy is chosen: size small, medium
or large. Each plate is anatomical and suitable for either left or right side. The Calcanea® plate is then positioned
at the appropriate location on the lateral calcaneal wall.
Most of the time, the posterior facet is first restored, with the medial facet in relation to the sustentaculum tali, the
anterior facet and at last the posterior tuberosity. These steps should enable the surgeon to restore the length and
width of the calcaneus.
Three areas of dense cortical bone will
hold fixation well:
• distal portion of the calcaneus (near
the calcaneocuboid joint),
• below the angles of Gissane (below
the posterior facet),
• the tuberosity.
A triangle of soft cortical bone in the
middle portion of the calcaneus is a
neutral triangle that will not hold a
screw well.
6 • CALCANEA® • SURGICAL TECHNIQUE
If necessary the Calcanea® plate can be moulded and contoured to the lateral aspect of the anterior process, the
posterior facet and to the tuberosity. The upper part of the posterior and anterior borders can sometimes be cut
off, or be bent for a dorso-plantar screw fixation. Plate benders (2 x 129 139ND) should be used for this bending
procedure.
3rd step: Calcanea® plate fixation with locking screws
The drilling sleeves (129 135ND) are first screwed in the hole located on the anterior extremity and in the 2 holes
on the posterior extremity of the plate. They allow axial drilling and perfect insertion of the locking screws. The
holes for fixation screws are drilled using the 2.2 mm drill (119 006ND) through the drilling sleeves.
CALCANEA® • SURGICAL TECHNIQUE • 7
The positioning of the locking screws on
the CALCANEA® plate creates a frame
through which the stress forces are
running and kept to a minimum.
•: holes for locking screws (size large)
The plate is fixed using
specific 3.5 mm screws
(180 XXXND). The
appropriate length
of the screws to be
inserted is evaluated
using the depth gauge
(129 134ND).
Color coding of each
size of screw allows
for quick choice of the
adequate length to be
used.
8 • CALCANEA® • SURGICAL TECHNIQUE
4th step: Calcanea® plate fixation with variable angle
screws
The variable angle screws can be introduced in the other holes (non-threaded) of the plate, depending
on the bone fragments to be fixed. The drill guide (129 130ND) and the drill diameter 2.2 mm (119
006ND) are used to perform the holes and adjust the orientation of the screws.
The appropriate length of the 3.5 mm
screws (180 XXXND) to be inserted is
evaluated using the depth gauge
(129 134ND).
Holes in the plate allow fixation with up to 4 screws in the posterior tuberosity (2 locking screws and 2
variable angle screws), and 3 screws in the anterior process (1 locking screw and 2 variable angle screws).
If there is a fracture of the anterior process of the calcaneus, it will be temporarily stabilized with
Kirschner wires.
The screws are inserted with the specific screwdriver (129 132ND) in a normal way, and introduced in the
bone until the base of their head is blocked against the plate.
CALCANEA® • SURGICAL TECHNIQUE • 9
Postoperative care
The patient should receive antibiotic and antithrombotic prophylaxis. Before the wound suture, suction drainage is
performed and will be carried out for two days. The postoperative care consists of partial weight-bearing, for 4 to 6
weeks, depending on the comminution, and then physiotherapy and progressive loading. Sagittal ankle joint motion is
started after suction drain removal. Eversion and inversion movements are started after stable wound healing.
Removal of the material
After 1 year, it is advised to remove the material. The Calcanea® plate has been designed to enable easy removal. All
the screws inserted in the plate can be removed using a regular 3.5 mm screwdriver. An arthrolysis for improvement
of the subtalar joint motion is mandatory.
10 • CALCANEA® • SURGICAL TECHNIQUE
NON-STERILE IMPLANTS • SINGLE USE
In accordance with EEC directive 93/42 relative to medical
devices, this product must be handled and/or implanted by
WELL-TRAINED, QUALIFIED PERSONS, AWARE OF THESE
DIRECTIONS FOR USE.
1 - Description of the medical devices:
The implants - delivered non-sterile - are:
- Osteosynthesis plates, existing in different models and sizes
- They are made out of Titanium alloy within the frame of the
standard ISO 5832-3 and ASTM F136
2 - Indications:
The CALCANEA® plate is indicated for use in fixation of:
- fractures or osteotomies of the calcaneus.
3 - Contraindications:
The implant should not be used in a patient who has currently, or
who has a history of:
- Local or systemic acute or chronic inflammation;
- Active infection or inflammation;
- suspected or documented metal allergy or intolerance;
4 - Warnings:
Serious post-operative complications may occur from use of the
implant in a patient who:
- Has severe osteoporosis;
- Has immunological responses, sensitization, or hypersensitivity
to foreign materials;
- Lacks good general physical conditions;
- Demonstrates physiologic or anatomic anomalies that might
result in significant post-operative complications;
- Systemic or metabolic disorders;
5 - Precautions for use:
Physician must determine if implant is appropriate for patients
who have any of the following conditions:
- Drug and/or alcohol and/or smoke addiction and/or abuse;
- Infectious disease;
- Malignancy;
- Local bone tumors;
- Systemic or metabolic disorders or replacement;
- Compromised wound healing;;
- Obesity;
- Demonstrated psychological instability, displayed a lack of
understanding, inappropriate motivation, or attitude;
- Unwillingness to accept the possibility of multiple surgeries for
revision or replacement;
- Lacks an understanding that a metallic implant is not as strong
as normal healthy bone and will bend, loosen, or fracture if
excessive demand is placed on it;
- Lacks an understanding that their preoperative capacity may not
be fully recovered even after successful implantation;
Knowledge of surgical techniques, proper reduction , selection
and placement of implants, and post-operative patient
management are considerations essential to a successful
outcome.
Criteria for patient selection is the responsibility of the surgeon.
Information contained within this document should be taken into
consideration during the selection process. Recognition of the
appropriate indications and contraindications and the selection
of the proper surgical procedures and techniques determined to
be best for the patient are the responsibility of the surgeon. Each
surgeon must evaluate the appropriateness of the procedure and
instruments used during the procedure based on his or her own
training and experience.
The surgeon should discuss with the patient prior to surgery
possible risks, precautions, warnings, consequences,
complications, and adverse reactions associated with the surgical
procedure and implantation of the device.
Each patient must be evaluated by the surgeon to determine the
specific risk/benefit relationship in light of the patient’s condition
and the surgeon’s practice, training, experience, and knowledge
of the related medical literature.
Complications with the use of osteosynthesis plates have been
reported in the medical literature. Any patient undergoing a
surgical procedure is subject to intra-operative and post-operative
complications. Each patient’s tolerance to surgery, medication, and
implantation of a foreign object may be different.
Possible risks, adverse reactions, and complications associated
with surgery and the use of the osteosynthesis plates should be
discussed with and understood by the patient prior to surgery.
The implant is composed of titanium alloy materials; therefore,
it is subject to possible reactions and complications, including
those listed herein. The patient should not be led to unrealistic
expectations as to the performance or results that the surgery and
implant can provide. The patient should be informed that the life
expectancy of the device is unpredictable once implanted, and that
successful results cannot be guaranteed.
IT IS THE RESPONSIBILITY OF THE SURGEON TO PROVIDE THE
PATIENT WITH INFORMATION PRIOR TO SURGERY.
Complications may include but are not limited to:
-- Pain, discomfort, or abnormal sensations due to presence of
the implant;
-- Bending, loosening , and/or breakage, which could make
removal impracticable or difficult;
-- Risk of additional injury from post-operative trauma;
-- Migration of the implant position or implant material resulting
in injury;
-- Bone loss due to stress shielding;
Side effects may include but are not limited to:
-- Infections;
-- Hematoma;
-- Allergy;
-- Thrombosis;
-- Bone non union or delayed union .
Adverse effects may necessitate re-operation, revision or removal
surgery , arthrodesis of the involved joint, and /or amputation
of the limb.
Implant removal should be followed by adequate postoperative
management to avoid fracture or re-fracture.
Interference risks during medical imaging: MRI/SCANNER: ask
the patient to systematically mention that he/she was implanted
with a metallic device.
6 - Instructions for reprocessing:
This product is sold non-sterile.
Check the integrity of the packaging and labeling before opening
the packing.
Remove all the products from their packaging prior to sterilization
All products should be cleaned, decontaminated, and sterilized
before use.
Always immediately clean and decontaminate all devices that
have been soiled.
Repeated reprocessing has little effect on these products.
Preparation: Double instruments (ex. Internal screwdriver and
associated external screwdriver) should be separated prior to
cleaning.
Cleaning: Cleaning can be performed manually, automatically or
ultrasonically in accordance with the specifications designated by
the manufacturer of the hospital’s equipment.
Manual cleaning:
Manual cleaning consists of using aldehyde free cleaners (neutral
or alkaline), applied with a soft brush, taking special care to
threaded parts and parts difficult to reach.
Note: Certain solutions such as those containing bleach or
formalin may damage the devices, and they must not be used.
Use of metallic brushes or other abrasive products is also
forbidden.
Cleaning should be immediately followed by profusely rinsing
with deionized water. Check that water flows out the cannulated
parts.
Automatic cleaning:
Automatic cleaning is performed in a cleaning/disinfecting
machine using neutral cleaners, with a cleaning cycle of 5
minutes minimum and a rinsing cycle of 3 minutes.
Check the complete removal of visible dirt, especially in the
cannulated parts.
If necessary, repeat the full process or proceed to a manual
cleaning.
Disinfection: If an automatic cleaning is used, final rinsing at
80°C during 10 minutes can be performed.
Drying: Drying temperature should not exceed 95°C.
Controls, servicing and tests: No specific requirements. The
implants are single use. They should therefore never be re-used.
Packaging: No specific requirements.
Sterilization: Newdeal’s implants and instruments are
recommended to be sterilized by the steam autoclaving procedure
regularly used in the hospital.
The following two methods have been validated by the
manufacturer and can thus be used:
Method: steam Method: steam
Cycle: wrapped gravity Cycle: wrapped gravity
Temperature: 132°C Temperature: 134°C
Exposure time: 45 minutes Exposure time: 18 minutes
Other sterilization method and cycles may also be used. However,
individuals or hospitals not using the recommended method are
advised to validate the alternative method using appropriate
laboratory techniques.
EtO sterilization or cold sterilization techniques are not
recommended.
7 - Use of the implant:
The surgeon must use the instrumentations recommended in
accordance with the operative technique available from the
manufacturer. The medical device must be used in compliance
with the use of the profession and the standard of art. Do not
attempt a surgical procedure with faulty, damaged or suspect
instruments or implants. Inspect all components preoperatively
to assure utility. Alternate fixation methods should be available
intraoperatively.
Opening of the instruments set must be done according to aseptic
condition.
When handling the implants, av