Kryptonite - KLS Martin

CMF Surgery
Kryptonite
Cranioplasty Case Reports and Early
Experience with Kryptonite Bone Cement
as a Cranial Bone Void Filler
■ Adhesive
■ Porous
■ Bone-like Properties
■ Low Exotherm
■ Non-toxic

Kryptonite Bone Cement is non-toxic, with bone-like
mechanical properties, and composed of naturally
occurring fatty acids and calcium carbonate. The unique
properties of Kryptonite Bone Cement make it well
suited for cranial applications and distinguish it from
PMMA and tricalcium phosphate/hydroxyapatite based
products.
Kryptonite Bone Cement can be mixed and delivered
by hand or utilizing a number of commercially available
mixing systems.

Kryptonite: Bone Cement
Kryptonite
Cranioplasty Case Reports and Early
Experience with Kryptonite Bone Cement
as a Cranial Bone Void Filler
Abstract
Two cranial repair cases are presented in which Kryptonite Bone Cement was
used to fill bone voids. In the first case, a 63-year-old female with a basiloma
adjacent a preexisting 25 cm 2 occipital defect underwent cranioplasty with
Kryptonite Bone Cement. At 5-month follow up, the implant was stable,
neurological assessment was normal and the patient had resumed recreational
activity.
In the second case, a surgical technique is described for filling a cranial void
following excision of an eosinophilic granuloma.
Lastly, a review of 27 cranioplasty procedures is presented. These cases report
no device-related adverse events, demonstrating the safety profile of this unique
bone void filler in cranial applications.
Kryptonite material has received a CE mark for use in Europe as a self-setting bone
filler for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Kryptonite material is a resinous material for the repair of bony defects that may be
shaped and gently applied to cranial defects.
Kryptonite material has regulatory clearance in Australia (TGA) and in Canada
(Health Canada Approved).
Kryptonite material has obtained marketing authorization from the United States
Food and Drug Administration as a bone cement with indications for use as a resinous
material for filling cranial defects.
3

Background
4
Kryptonite: Bone Cement
Kryptonite
Cranioplasty Case Reports and Early
Experience with Kryptonite Bone Cement
as a Cranial Bone Void Filler
Documented cranioplasty procedures date back to the 16 th century
when gold plates were used to fill voids created by trepanation.
Through the following centuries, surgeons have explored
the use of xenografts, allografts, autografts, metals and modern
plastics in the search of a safe and effective cranioplasty solution.
Polymethylmethacrylate (PMMA) has become the standard of
care and has excellent mechanical properties, but it does exhibit
several deficiencies.
■ During the polymerization process PMMA can reach temperatures
in excess of 93°C; hot enough to necrose neural tissue.
■ The structure of PMMA does not allow osseointegration, and
the material is frequently walled off from the host bone by a
layer of fibrous tissue. PMMA contains a toxic monomer that
is a health concern for the operating room staff and has the
potential to leach from the product and into the host tissue.
■ PMMA is not adhesive and instead simply fills the space into
which it is implanted, thus relying on geometric features to
maintain its position.
More recently, calcium phosphate based osteoconductive cements
have been used clinically. Although these materials allow for bone
ingrowth, their mechanical properties, most notably their tensile
strengths, are significantly lower than PMMA, and implant failures
have been reported. 1
Kryptonite Bone Cement, a novel in situ curing structural
adhesive that polymerizes to form a porous scaffold, 2 offers the
potential to address the limitations of these historical solutions
and provides a safe and efficacious means of repairing cranial
defects.

CT axial scan and reconstruction of occipital defect
filled with 10 cc kit of Kryptonite Bone Cement
Case 1
Cranioplasty reoperation for basiloma /
cranial meningocele
A 63-year-old female, non-smoker presented with a large basiloma
adjacent an occipital defect present from an earlier pediatric
cranial meningocele. The defect measured approximately 25 cm 2
and was positioned over the occipital midline. After excision
of the tumor, scar tissue within the defect was removed, bone
was exposed, and the area was rinsed clean with saline.
A 10 cc kit of Kryptonite Bone Cement was mixed per the
manufacturer’s instructions, delivered to the defect and contoured
to conform to the patient’s occipital anatomy. Upon placement,
the material was allowed to cure for an additional 30 minutes,
at which time it was sufficiently rigid to maintain its shape.
The incision was closed per standard technique, the patient was
sent to postoperative care and no immediate postoperative
complications were noted.
The patient returned to the clinic five months after surgery. She
was taking no medications, had resumed moderate recreational
activity and in assessing the surgical outcome, she reported being
“very satisfied” with the treatment. Her neurological assessment
was normal and KPS (Karnofsky Performance Status) score was
100. CT scans showed an intact implant that had maintained its
original position.
5

Case 2
6
Kryptonite: Bone Cement
Preoperative MRI showing eosinophilic granuloma Cranial defect before and after application of Kryptonite Bone Cement
Cranioplasty after excision of Eosinophilic Granuloma
A child presented with an eosinophilic granuloma that was
excised per standard techniques that required cranioplasty on
an approximately 2 cm diameter defect. In shaping the defect,
the surgeon created an undercut geometry such that the exterior
diameter of the defect was narrower than the internal diameter,
providing a shape to resist expulsion of the implant. The surgeon
positioned the patient with the defect parallel to the floor to
prevent the material from flowing out of the defect during initial
polymerization.
Kryptonite Bone Cement was mixed per the manufacturer’s
instructions and allowed to partially polymerize in the mixing
dish for 10 minutes prior to handling. The defect was irrigated
with saline and gel foam was placed over the dura. Once the
material had reached an adhesive state it was placed in the
defect using a spatula. Accounting for the expansion that occurs
during the polymerization process, the void was only half filled,
and during the next 10 minutes the material expanded to completely
fill the void. Wet surgical gloves were used for final contouring
of the material. A surgical sponge was lightly pressed
against the Kryptonite Bone Cement material to assess
the state of adhesiveness. When the sponge no longer adhered
the incision was closed per standard technique.

Review of Early Experience with Kryptonite
Bone Cement as Cranial Bone Void Filler
Kryptonite Bone Cement is CE-marked, TGA cleared in Australia
and Health Canada approved for human clinical use and has been
used in approximately 3,000 human clinical cases throughout
Europe, Latin America, and Canada. Due to the relative infrequency
of cranioplasty procedures, only a small number of these 3,000
cases utilized Kryptonite Bone Cement as a cranioplasty
cement.
Doctors Research Group, Inc. is aware of 38 such cases through
2008 and undertook the effort of collecting retrospective clinical
data on this patient population. Twenty-seven patients consented
to participation in the retrospective chart review and interview,
and 14 of these agreed to a follow-up CT scan. A summary of
the patient demographic data is provided below:
Attribute Result
Sex Male: 12
Female: 15
Age Mean: 50 years
Mean Female: 55 years
Mean Male: 43 years
Race Caucasian: 26
African: 1
Smoker Current: 6
Non: 19
Former: 2
The clinical conditions that required cranioplasty were varied
and included among others: meningioma, cranial vault decompression,
drug resistant epilepsy and reconstruction of skull base
after endonasal transtubercular-transplanar approach. These 27
procedures are considered to be representative of all cranioplasty
procedures.
Time points for follow-up ranged from six weeks to 18 months.
Out of 23 patients providing feedback, 21 responded that they
were “very satisfied” or “somewhat satisfied” with the surgical
outcome. In the 27 cranioplasty cases, there have been no neurological
complications or abnormalities, no implant rejections, and
no other device-related effects. The cases serve to demonstrate
Kryptonite Bone Cement’s respectable safety profile. There
were no instances of infections secondary to Kryptonite Bone
Cement failure, as is often observed in cranial defects treated
with hydroxyapatite-based cements. 3 Review of the 14 follow-up
CT scans (average 5-10 months post-op) by an independent
radiologist showed no evidence of device failure or abnormal
occurrence.
Discussion
With respect to the first case, long term survivorship and normal
physical function is not the normal outcome for pediatric cranial
meningocele patients. 4 This patient beat the odds but, like others
with her condition, has undergone several surgical interventions
during her lifetime.
To improve survivorship in such patients, and to generally improve
the outcomes of cranioplasty procedures, there exists a need for
an in situ curing material with adequate strength, low exotherm,
adhesiveness to bone, low toxicity, and porous structure. Laboratory
testing has shown Kryptonite Bone Cement satisfies these
requirements and recent clinical successes like those presented
here are further proving its safety and efficacy.
The surgical technique described in the second case report highlights
the subtle differences in handling and polymerization rate
relative to both PMMA and calcium phosphate based void fillers.
Additionally, Kryptonite Bone Cement’s adhesiveness and in situ
expansion are unique characteristics that should be appre-ciated
by the surgeon prior to initial use. Familiarity with the product,
gained through hands-on evaluation and training from experienced
users, will lead to predictable use and desirable outcomes with
this truly novel product.
References:
1. Goldberg et al
“Measuring pulsatile forces on the human cranium”,
Journal of Craniofacial Surgery,
16 (1), pp 134-139, 2005.
2. Data on file at Doctors Research Group, Inc.
3. Moriera-Gonzalez et al
“Clinical outcome in cranioplasty: critical review in
long-term follow-up”,
Journal of Craniofacial Surgery, 14(2):144-153, 2003.
4. Althouse R and Wald N
“Survival and handicap of infants with spina bifida,”
Arch Dis Child, November;
55 (11): 845-850, 1980.
7

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Kryptonite material has received a CE mark for use in Europe as a self-setting
bone filler for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Kryptonite material is a resinous material for the repair of bony defects that may be
shaped and gently applied to cranial defects.
Kryptonite material has regulatory clearance in Australia (TGA) and in Canada
(Health Canada Approved).
Kryptonite material has obtained marketing authorization from the United States
Food and Drug Administration as a bone cement with indications for use as a resinous
material for filling cranial defects.
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Doctors Research Group, Inc.
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