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Schematic Lateral View
Fig. 1: Schematic lateral view post-op
Fig. 2: Schematic lateral view post-distr
Clinical Examples
Fig. 3: Pre-op view I
Fig. 4: Pre-op view II
Fig. 5: Post-distr view I
Fig. 6: Post-distr view II
Ordering Details:
The Riediger Midface Distractor
51-560-15
51-560-20
51-561-15
51-561-20
Left, distraction length 15 mm
Left, distraction length 20 mm
Right, distraction length 15 mm
Right, distraction length 20 mm
51-562-06
51-562-09
51-562-12
Soft tissue protection sleeve, 6 mm
Soft tissue protection sleeve, 9 mm
Soft tissue protection sleeve, 12 mm
1
⁄1
Recommended Instruments:
25-430-16
25-486-13
25-441-16
25-435-15
51-512-90
25-451-07
Centre Drive® screwdriver 1.5 mm
Modelling pliers (two are recommended)
Plate holding forceps
Plate holding forceps Lindorf
Patient screwdriver
Drill bits 1.1 x 50 x 7 mm, cylindrical (5 each)
1
⁄3
alternative:
25-451-08 Drill bits 1.1 x 50 x 7 mm, Stryker attachment (5 each)
Recommended Screws:
25-665-03
25-665-05
25-665-06
25-665-07
25-666-05
Centre Drive®
Centre Drive®
Centre Drive®
Centre Drive®
Centre Drive®
screws 3.5 x 1.5 mm (5 each)
screws 5 x 1.5 mm (5 each)
screws 6 x 1.5 mm (5 each)
screws 7 x 1.5 mm (5 each)
emergency screws 5 x 1.8 mm (5 each)
KLS
International Partners in Oral, Plastic
and Craniomaxillofacial Surgery
02.04 . 90-123-02-04 . Printed in Germany
Copyright by Gebrüder Martin GmbH & Co. KG
Alle Rechte vorbehalten.
Technische Änderungen vorbehalten.
We reserve the right to make alterations.
Cambios técnicos reservados.
Sous réserve de modifications techniques.
Ci riserviamo il diritto di modifiche tecniche.
Gebrüder Martin GmbH & Co. KG
+,3-ARTIN0LATZ . D-78532 Tuttlingen
Postfach 60 . D-78501 Tuttlingen . Germany
Telefon +49 (0) 74 61 706-0
Telefax +49 (0) 74 61 706-193
[email protected]
www.martin-med.com
Sales Organisation North America and Canada
KLS Martin L. P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, Fl 32246
Office phone (904) 641-7746
Office fax
(904) 641-7378
WATS
(800) 625-1557
Distraction
Osteogenesis
The Riediger Midface Distractor
Internal distraction of severe mid-facial hypoplasia
www.martin-med.com
Introduction
The therapy of cases with severe midfacial hypoplasia
(i.e. Crouzon’s disease and other syndromes, posttraumatic
cases) continues to be a problem in cranio-maxillofacial
surgery. Le Fort III osteotomy and other surgical procedures may offer a solution in those patients. However the
amount of ventral move might be restricted due to anatomical limitations (optical nerve) and postoperative retromaxillary scar formation, especially in children.
Distraction lengthening, a technique first described by
Codivila in 1905, delineates a method for generating new
bone by stretching or lengthening of callus. This concept
was popularized by Ilizarov who recognized the inherent
capacity of the callus tissue. Bone lengthening by distraction osteogenesis through gradual distraction is a wellknown procedure for the reconstruction of the mandible.
Midface distraction osteogenesis has some distinctive
advantages when compared to conventional treatment.
First of all there is no need to use and harvest bone transplants. This means less operating time and less morbidity.
Also earlier correction of severe midfacial retrusion becomes possible. Unlike conventional osteotomies, osteotomies
with distraction osteogenesis can be performed very early
in childhood. This means less psychological problems and
earlier correction of the deformity. Midfacial Le Fort III
advancement for the correction of midfacial hypoplasia by
distraction osteogenesis has been used by some authors.
The extra-orally applied halo frames are sometimes not
well accepted by the patients because they limit, especially
children, in their daily activities such as sport. Internal
devices, developed by several authors, have the drawback
that they don’t allow precise advancement of the osteotomized segment and closure of the open bite which often
accompanies midfacial hypoplasia treatment.
The Riediger Midface Distractor was developed to
overcome these problems.
The new design allows for easy internal fixation and
temporal positioning with convenient activation of the
device.
Indications:
1
⁄1
Midfacial retrusion and hypoplasia due to trauma
or congenital deformities whereas correction by a
(modified) LeFort III advancement is necessary.
Contra-indications
• In cases where there is insufficient bone volume or
quality for a secure planning of the distraction.
1
⁄1
Developed in cooperation with
Univ.-Prof. Dr. Dr. med. D. Riediger
Dept. for Oral-, Maxillofacial and Plastic Surgery
University Hospital Aachen, Germany
• A general contra-indication is a severely diseased system:
immune deficiency – irradiated patients – severe diabetes.
Design of the distractor
Advantages
The distractor is fabricated out of medical grade titanium in
two versions, one for the right side and one for the left side.
It consists of a distraction cylinder with an internal expansion system and a lateral activation rod (Fig.1).
• Miniaturized internal (subcutaneous) system that
is almost invisible and doesn’t interfere with daily
activities
Five clockwise turns of 360° each of the activation rod gives a
distraction distance of 1 mm. At the posterior end a malleable mesh plate with 18 holes and at the anterior end a
tiltable plate with 4 holes is connected. The distractor is
thus designed to allow a stable fixation to the bony
segments. The connection at the posterior end
allows rotation of the distraction cylinder in
a lateral plane. At the posterior temporal side, the distractor can be fixated
with a maximum of 18 short, monocortical 1.5 mm micro titanium
screws of 3 mm length. Longer
screws are not advised due to
the possibility of perforating
and harming the dura mater
in cases of thin temporal bone,
especially in children.
The anterior plate can be
fixated with longer, bicortical
screws in the frontal process of
the zygoma. The connection to
the anterior plate is composed out
of a ball joint and allows rotation in
the sagittal plane. This ball joint facilitates adjuvant orthodontic therapy.
Being a unique and patented feature, the lateral
activation rod is constructed perpendicular to the distraction cylinder and is accessible through a small cutaneous
incision in the pre-auricular area. A small soft tissue protection sleeve can be mounted onto the lateral activation rod in
order to allow activation. After the distraction phase has
come to an end, the soft tissue protection sleeve can be
removed and the distraction device becomes fully submerged. The soft tissue protection sleeve is available in
three different lengths (6, 9 and 12 mm). The distractor
is available with two different distraction lengths (15 and
20 mm).
• Lateral activation of the distractor facilitates the procedure for the patient
• Design allows adjuvant orthodontic therapy and
maximum steering of the occlusion
• Design makes a stable positioning and
functioning of the distractor possible
(fixation with multiple screws)
• Specially designed 1.5 mm
micro screws (monocortical)
allow stable fixation to the
temporal bone without
perforating the temporal
bone and harming the
dura mater
• The soft tissue protection sleeve can be
removed after distraction
and the device becomes
fully submerged.
The chance for infection and
necessity for early removal of
the device are therefore minimal.
Special notes
Prior to implantation, a 3D-CT scan and/or the production of a stereolithographic model is advisable in
order to define the optimal position and vector of the
distractor and to check the thickness of the temporal
bone.
Intra-operative approach
Insertion of the distractor
A bicoronal scalp incision gives wide exposure
of the orbits, nose and subtemporal fossae with
direct access to the retromalar areas as necessary
for the Le Fort III approach. Osteotomies are made
across the frontonasal juncture and medial walls of
the orbits behind the lacrimal crest with the microsaw and osteotome. Subsequently the midface has
to be mobilized with disimpaction forceps and
slightly advanced forward. Two distractors (one
at the left side and one at the right side) are positioned and fixated. The distractors can be fixated
in the temporal area with short 1.5 mm titanium
micro screws. The anterior plate can be fixated
with longer titanium screws. Pre-operative and
intra-operative test activation of the distractors
must be performed in order to check the function
of the devices. In case of hemifacial deformities
such as hemifacial microsomia, a hemifacial osteotomy of the orbit, zygoma and maxilla with the
appliance of one distractor may be performed.
A prophylactic antibiotic scheme, starting at the
induction, for at least two days is advised in order
to minimize the risk of infection.
Distraction protocol
• 0.5 or 1.0 mm distraction per day in one
or two sessions
• Latency period: 1 week
• Stabilization / Retention time: 3 -6 months
Activation of the distractor
After a latency period of one week, a small incision
in local anesthesia in the pre-auricular area can be
made to expose the lateral activation rod, which is
easily palpable subcutaneously by this time. The soft
tissue protection sleeve has to be screwed onto the
activation rod in order to start distraction. Latency
time and distractor activation follows a standard protocol.
Activation can be started one week after placement
of the distractors. A distraction rhythm of 1 mm per
day in one session or two sessions can be applied.
It is advisable to start up adjuvant orthodontic at this
time. After obtaining the planned distraction distance,
the soft tissue protection sleeve can be removed and
the small wound sutured. In this manner the distraction device becomes fully submerged.
Removal of the distractor
The distractors can be removed three to six months
after placement by two small incisions: one in the
temporal area and one at the lateral orbital ridge.
Regular follow-up with clinical examination and X-ray
evaluation is advisable. The distractor is designed
for single use only!
Literature References
• Ilizarov GA
The principles of the Ilizarov method.
Bull. Hosp. Joint Dis. 48:1, 1988.
• Molina F.
Distraction of the Maxilla.
In J. G. McCarthy (Ed.) , Distraction of the
Craniofacial Skeleton, New York: Springer
Verlag, 1997.Pp. 308-320.
•McCarthy J.G., Schreiber J., Karp N. et al.
Lengthening of the mandible by gradual
distraction.
Plast. Reconstr. Surg. 89:1, 1992.
Ident number:
On each label one will find an ident number.
In case of complaints please use the indicated
numbers for traceability. It is advisable to attach
the ident number to the patient’s file.
Cleaning and sterilization:
The distractor has to be cleaned prior to sterilization by using a neutral cleaning agent.
Sterilizing in an autoclave with max. temperature
of 134°C is recommended.
Bending procedure:
To avoid mesh plate damage during the bending
procedure, please use always two bending pliers
ref. no. 25-486-13.