Applications of Bioabsorbable Fixation System

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Applications of

Bioabsorbable Fixation System


in Oral & Maxillofacial Surgery
Titanium Plates & Screws
 Problems in young children
 Passive translocation – embedded in dura
 Growth disturbances
 Radiological problems
 Artifacts from CT or MRI
 Radiographic traces
 Miscellaneous
 Release of corrosion products
 Thermal conductivity
 Unacceptable palpability
Bioabsorbable Plates & Screws
 Advantages
 No secondary removal
 No scattering or ferromagnetic effect
 No adverse effect on normal bony growth
 Disadvantages
 Bulky mass for the compensation of
weakness
 Possibility of foreign body reaction or
osteolysis around the screws and a long
degradation period
Polymers of Bioabsorbable System
 PLA (polylactides)
 PGA (polyglycolides)
 PLLA (poly-L-lactides)
 Addition of D-lactide
Reduction of crystallinity
Increase of biodegradability
 Self-reinforced poly-L/D lactide (SR-
PLDLA): 70% L-lactide & 30% D-lactide
Bioabsorbable Osteofixation System
Bionx (Linvatec) Leibinger
Synthes Inion CPS
BioSorb Delta system

L-lactide
PLLA/PDLLA PLLA/PDLA/PGA PLLA/PDLLA DL-lactide
Polymer
70/30 85/5/10 70/30 Glycolide
TMC

Semi-crystalline
Shape Semicrystalline Amorphous Amorphous
SmartScrew:crystalline

Sterilization g-sterilization ethylenoxide g-sterilization g-sterilization

Absorption 16~24 months 24-36 months 24-36 months 12-48 months


9-14weeks later70%
Strength 6months later 70% 6months later 50% 8weeks later 70%

Skull & Midface


(Trauma&Orthognatic) Skull & Midface Skull & Midface Skull & Midface
Indications
※Mn. Reconstruction (Trauma) (Trauma) (Trauma&Orthognatic)
※Mn. BSSRO Screws

※ FDA Approved
Bioabsorbable Osteofixation System
Bionx(Linvatec) Leibinger
Synthes Inion CPS
BioSorb Delta system

Room Temp. bendable Water-bath @ 700C Water-bath @ 60~700C Water-bath @ 550C


Bending
method
Bending pliers 2~3sec in Water-bath 10sec in Water-bath 15sec in Water-bath

System size 1.5/2.0/2.4(mm) 1.7/2.2(mm) 1.5/2.0(mm) 1.5/2.0/2.5/2.8(mm)

Plate width 5.5/5.5/8.0(mm) 7.5/8.5(mm) - 5.5/7.5/8.5(mm)

Plate
1.0/1.2/1.4(mm) 1.0(mm) 0.8/1.2(mm) 1.2/1.7/2.0(mm)
Thickness
Mesh
0.6/0.8/1.0(mm) 0.75(mm) 0.5/0.8/1.2(mm) 0.5/0.6/0.7(mm)
thickness

Screw shape Cruciform Straight Cruciform Cruciform

Tap Standard Standard Standard Standard

Driver Standard Torque controllable Standard Standard


Indications
 Trauma Surgery
 Simple fractures of the maxilla
 Non-complicated simple mandibular fractures
 Orbital floor fractures (blow-out)
 Fractures of the zygomatic arch
in the frontozygomatic suture or buttress area
 Elective surgery
 Correction of congenital deformities
of the skull / of the maxilla / of the mandible
 Fixation of costchondral grafts
 Tumor surgery
fixation of access osteotomies or microvascular grafts
 Tissue engineering and guided bone regeneration
Bending
Plate Adaptation
Drilling Angulation
LeFort I Osteotomy
Genioplasty
BSSRO
Radiographic Findings
Bicortical Screws
Bicortical Screws

From Riitta Suuronen’s presentation modified by Mikko Latvala


Mn. Fx. – Symphysis
Complication
Complication
Mandibular Reconstruction

From Riitta Suuronen’s presentation modified by Mikko Latvala


Cranioplasty

From Riitta Suuronen’s presentation modified by Mikko Latvala


Clinical Research
.

Application of Bioabsorbable Plates in


Orthognathic Surgery
Young-Kyun Kim*, Pil-Young Yun
Department of Oral & Maxillofacial Surgery, Section of Dentistry,
Seoul National University Bundang Hospital

Purpose
 Evaluate the clinical results and complications
of application of bioabsorbable plates and
screws in orthognathic surgery
Clinical Research
Materials and Methods
 The research protocol was approved by the
Institutional Review Board on Human Subjects
of the SNUBH.
 May 2003 ~ Dec 2004, orthognathic surgery
 The same surgeon and assistants
 The same surgical protocol
 Biosorb plate and screws (Biosorb FX,
Bionximplants, Inc., Finland)
Clinical Research
 Biosorbable plate fixation
 Manual bending
 Pretapping and screw fixation (6.0~8.0mm)

 BSSRO: Single 4-holed or 6-holed 2.4mm


plate
 Genioplasty: two 2.0mm 3 or 4-hole
 LeFort I osteotomy: four 4-holed 2.0mm
plates
Clinical Research
 Patients characteristics
 Total 54 patients (17 male, 37 female)
 Age: 15-52 years (mean 22.6)
 F/U: 8-24 months (mean 15)
 MMF: 7-14 days (mean 8.3 days)

 Results
 Complications: 5 patients (9.3%)
All infection: I & D, Medication
 No other complications related with physical or
mechanical properties of bioabsorbable system
Case Summary
Diagnosis No.(M/F) Types of No. of Patients No. of plates Complication
surgery
Facial 13(7/6)
Mx. Osteotomy 13 52 0
asymmetry
Le Fort I 13 52 0
Advancement 5 20 0
Mandible 39(10/29) Impaction 8 32 0
Prognathism
Mn. Osteotomy 72 144 5
Mandible 2(0/2) BSSRO 52 104 5
Retrognathism Advancement 1 2 1
Set-back 51 102 4

Total 54(17/37) Genioplasty 20 40 0


Advancement 4 8 0
Set-back 6 12 0
Reduction 10 20 0

Total 85 196 5
Clinical Research
 Conclusion
 It is attractive to use bioabsorbable
materials as fixation devices.
 The Use of bioabsorbable plate and screws
in orthognathic surgery will provide a
promising alternative of titanium internal
fixation devices in appropriate cases.

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