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BIODEGRA
DABLE
IMPLANTS
 The implants which undergo gradual
degradation by biological process and
absorbed and excreted by the body are called
Biodegradable Implants.
Why biodegradable implants?
 There will be need for a second operation for
removal of metallic implants,with considerable
additional inconvenience,expense and at some
risk of operative complication.
 This led to the development of so called
biodegradable/bioabsorbable/biologically inert
implants which undergo gradual degradation after
their purpose is being served.
HISTORY
 The history of absorbable implants in the
repair of bone tissue began in late 1960’s.
 The first studies were performed in the field
of maxillofacial and mandibular surgery.
 Implants of more complex design,such as
screws and small plates became possible in
late 1970’s and early 1980’s.
Types of materials
 Polyglycolic acid
 Polylactic acid
 Polyparadiaxonone
Chemically these compounds
are Alpha polyesters.
Structure, strength and
properties
 Polyglycolic acid (PGA) is a hard, tough, crystalline polymer
with an average molecular weight of 20,000 to 145,000 and a
melting point of 224-230°C.
 Polylactic acid (PLA)is a polymer with initial molecular
weights of 180,000 to 530,000 and a melting point of about
174°C.
 In orthopaedic implants Poly-L-lactic acid (PLLA) has been
used more extensively because it retains its initial strength
longer than Poly-D-lactic acid (PDLA).
 PGA belongs to the category of fast degrading polymers, and
intraosseously implanted PGA screws have been shown to
completely disappear within 6 months. PLLA on the other
hand has a very long degradation time and has been shown
to persist in tissues for as long as 5 years post implantation.
 Polyglycolic acid and polylactic acid
copolymers in a ratio of 90:10 and
polydiaxonose are used as absorbable
sutures world wide.
 The most important characteristic which
determines the behaviour of these polymers is
the glass transition temperature at which the
polymer becomes rigid and brittle.
 This ranges from 58 degree celsius for
polylactic acid and 16 degree celsius for
polypara diaxonone.
 The commercially available resorbable
polymers include pure polyglycolic (PGA) acid
in the form of PINS and SCREWS. Pure poly-
l-lactic acid (PLLA) and a co-polymer of PLLA
and PGA.
 They maintain most of their strength for 8
weeks and will completely resorb in the body
in 12–15 months.
BIODEGRADABLE
CERAMICS(CALCIUM
PHOSPHATE)
 Uses :
• Repair material for bone damaged with
trauma or disease.
• Void filling after resection of bone
tumours
• Repair and fusion of vertebrae
• Repair of herniated discs
• Repair of maxillofacial and dental
defects
• Drug-delivery
KNEE
 It is used extensively for ACL reconstruction in the form of
interference screws and transfixation screws.
 Osteochondral fractures can be well fixed by using
arthroscopic techniques and biodegradable pins.
 Meniscal tacks and biodegradable suture anchors have
opened new avenues for soft tissue reconstruction in
complex knee injuries.
 At 5 years, this bioaborbable interference screw
appeared clinically safe and MRI showedcomplete
absorption and replacement with new bone.
Shoulder
 Biodegradable implants provide viable options
for the repair and reconstruction of rotator cuff
tears, shoulder instability, and biceps lesions
that require labrum repair or biceps tendon
tenodesis.
 In a study of arthroscopic Bankart
reconstruction using either PGA polymer or
PLA polymer implants the overall clinical
results.
Spine
 Coe and Vaccaro published the first clinical series
using bioresorbable implants as interbody spacers in
lumbar interbody fusion. The clinical and radiographic
results allowed them to recommend the use of
bioresorbable devices in structural interbody support in
the TLIF procedure.
 Bioabsorbable polymer-calcium phosphate composite
cages were implanted in cervical spines; the latter
showed significantly better distractive properties, a
significantly higher biomechanical stiffness, and an
advanced interbody fusion.
.
FOOT and ankle
 Self reinforced absorbable implants
in medial malleolar fractures.
 Brunetti et al used bioresorbale
implants in the fixation of
osteotomies for hallux valgus.
 Bioabsorbable implants offer specific
advantages in the foot where
removal of the hardware is
mandatory in some fixations like
syndesmotic disruptions and
Lisfranc’s dislocations.
.
Cipro-screw
World’s first antibiotic releasing bioabsorbable fixation device
FEATURES OF IMPLANTS
 Tensile and flex strength
are comparable to titanium
plating system ,Plates are
easy to adapt with aid of
heat pack;
 A wide selection of implant
sizes an shapes are
available
 A convenient hex-drive
breakaway delivery system
simplifies screw placement;
 Eliminates growth restriction and implant
migration for paediatric craniofacial
reconstruction;
 Resorbs completely and may eliminate the
need for second operation;
 Does not induce late stage inflammatory
Mreaction.
 The headed bioabsorbable tissue anchor has
a large thread surface per turn of thread.
 As the anchor is turned into bone for
engaging cancellous bone, the disk-shaped
head engages and anchors the tissue to the
bone.
DEGRADATION AND
ELIMINATION
 The implants of polyglycolic acid,polylactic acid or
polydiaxonone are completely absorbable within
the bone tissue and the new bone is deposited on
or within the implant as the degradation proceeds.
 The degradation of these polymers occurs
1.Mainly by hydrolysis
2.And to lesser extent through non specific
enzymatic action.
 Factors which influence the degradation process
1.molecular weight
2.crystallinity
3.Thermal history
4.Geometry
Poly-lactic acid copolymers have the slowest rate
of degradation(half-life 6months)
 The co-polymers of polyglycolyic acid and poly
paradiaxonone are much more rapid.
 The principal route of elimination is respirationand to
lesser exent in urine and faeces.
DO U KNOW?
 The fact that the interfragmentary
compression cannot be achieved with
polyester pins or rods should be recognized
when the indications for the use of these
implants are being considered.
 Polyester screws do provide compression of
the fracture but are more difficult to insert than
the comparable metallic screws.
 Only fractures affecting the cancellous bone can be
managed effectively with the array of implants currently
available.
 At the moment the INDICATIONS for the
biodegradable implants are
1.Radial head Fracture
2.Wedge fractures of the patella
3.Fractures of the proximal and distal ends
of the metatarsals and metacarpals
4.osteochondrosis Dessicans or Osteochondral
fractures of the femur condyle.
5.Ankle Fracture
6.Adult capitellum Fracture
7.Displaced elbow fractures in children
8.Distal radius fracture
9.Pediatric fracture
10.Small fractures or osteotomies.
 Bioabsorbable meshes are available for
acetabular reconstructions.
 Bioabsorbable implants are also variously
used in cranio maxillo facial surgery and
dental surgery.
ADVANTAGES
1.No irritation of soft tissue
2.No Osteopenia
3.No need of secondary operation to remove
the implants.
4.Useful in pediatric fracture fixation.
5.No interference with the callus formation
and fracture healing.
6.Anti-biotic releasing Bioabsorbable screws
to reduce implant related infecion.
COMPLICATIONS
 The unique complication of these implants is
the delayed inflammatory reaction or sterile
inflammatory foreign body reaction.
 The other complications include
1.Failure of fixation
2.Postoperative wound infection
CLINICAL PRESENTATION
 The clinical presentation of the delayed sterile
inflammatory reaction is……
 The patient has no local or systemic signs of the
problems with the wound in the immediate post-op
period.,then a painfulerythematous,fluctuant
swelling suddenly develops about the healed
wound.
 The mean interval between the fixation of fracture
and clinical manifesation of reaction is twelve
weeks.
 A sinus draining the liquid remnants of the
implant material often form.
 Bacterial cultures of the drainage from the
sinuses are negative.
DRAWBACKS
 1.Fixation achieved with these type of implants is
often neither rigid not stable enough to hold the
fracture with motion or weight bearing force before
union.
 2.Cast support and use of cruchtes for lower
extremity fractures has been recommended,which
limits their further use.
 3.Bioabsorbable Implants have excessively low
moduli resulting in backing out of screws
 4.Poor handling characteristics when compared to
metals.
 5.The price of 45/50 mm fibre reinforced rod is
approximately 15 times that of a metallic
cancellous screw.
 6.The treatment of diaphyseal fractures of long
bones however would necessitate a larger device
such as a long plate and intramedullary nail,that
has a slow rate of degradation.
 Nevertheless the unsolved problem of
irritation of soft tissue and of osteopenia
beneath metallic plates will continue to
simulate research on absorbable implants.
FUTURE
 Resorbable plates can be covalently linked with
compounds such as HRP, IL-2, and BMP-2 and
represents a novel protein delivery technique. BMP-2
covalently linked to resorbable plates has been used to
facilitate bone healing.
 Covalent linking of compounds to plates represents a
noveL method for delivering concentrated levels of growth
factors to a specific site and potentially extending their
half-life.
 An area for future development would have to focus
developing implants that degrade at the “medium term”.
Since the screw that persists in its track for 5 years or
more does not offer the advantage of bioresorbability.
THANK
YOU

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Biodegradable implants

  • 2.  The implants which undergo gradual degradation by biological process and absorbed and excreted by the body are called Biodegradable Implants.
  • 3. Why biodegradable implants?  There will be need for a second operation for removal of metallic implants,with considerable additional inconvenience,expense and at some risk of operative complication.  This led to the development of so called biodegradable/bioabsorbable/biologically inert implants which undergo gradual degradation after their purpose is being served.
  • 4. HISTORY  The history of absorbable implants in the repair of bone tissue began in late 1960’s.  The first studies were performed in the field of maxillofacial and mandibular surgery.  Implants of more complex design,such as screws and small plates became possible in late 1970’s and early 1980’s.
  • 5. Types of materials  Polyglycolic acid  Polylactic acid  Polyparadiaxonone Chemically these compounds are Alpha polyesters.
  • 6. Structure, strength and properties  Polyglycolic acid (PGA) is a hard, tough, crystalline polymer with an average molecular weight of 20,000 to 145,000 and a melting point of 224-230°C.  Polylactic acid (PLA)is a polymer with initial molecular weights of 180,000 to 530,000 and a melting point of about 174°C.  In orthopaedic implants Poly-L-lactic acid (PLLA) has been used more extensively because it retains its initial strength longer than Poly-D-lactic acid (PDLA).  PGA belongs to the category of fast degrading polymers, and intraosseously implanted PGA screws have been shown to completely disappear within 6 months. PLLA on the other hand has a very long degradation time and has been shown to persist in tissues for as long as 5 years post implantation.
  • 7.  Polyglycolic acid and polylactic acid copolymers in a ratio of 90:10 and polydiaxonose are used as absorbable sutures world wide.
  • 8.  The most important characteristic which determines the behaviour of these polymers is the glass transition temperature at which the polymer becomes rigid and brittle.  This ranges from 58 degree celsius for polylactic acid and 16 degree celsius for polypara diaxonone.
  • 9.  The commercially available resorbable polymers include pure polyglycolic (PGA) acid in the form of PINS and SCREWS. Pure poly- l-lactic acid (PLLA) and a co-polymer of PLLA and PGA.  They maintain most of their strength for 8 weeks and will completely resorb in the body in 12–15 months.
  • 10.
  • 11.
  • 12. BIODEGRADABLE CERAMICS(CALCIUM PHOSPHATE)  Uses : • Repair material for bone damaged with trauma or disease. • Void filling after resection of bone tumours • Repair and fusion of vertebrae • Repair of herniated discs • Repair of maxillofacial and dental defects • Drug-delivery
  • 13. KNEE  It is used extensively for ACL reconstruction in the form of interference screws and transfixation screws.  Osteochondral fractures can be well fixed by using arthroscopic techniques and biodegradable pins.  Meniscal tacks and biodegradable suture anchors have opened new avenues for soft tissue reconstruction in complex knee injuries.  At 5 years, this bioaborbable interference screw appeared clinically safe and MRI showedcomplete absorption and replacement with new bone.
  • 14.
  • 15. Shoulder  Biodegradable implants provide viable options for the repair and reconstruction of rotator cuff tears, shoulder instability, and biceps lesions that require labrum repair or biceps tendon tenodesis.  In a study of arthroscopic Bankart reconstruction using either PGA polymer or PLA polymer implants the overall clinical results.
  • 16. Spine  Coe and Vaccaro published the first clinical series using bioresorbable implants as interbody spacers in lumbar interbody fusion. The clinical and radiographic results allowed them to recommend the use of bioresorbable devices in structural interbody support in the TLIF procedure.  Bioabsorbable polymer-calcium phosphate composite cages were implanted in cervical spines; the latter showed significantly better distractive properties, a significantly higher biomechanical stiffness, and an advanced interbody fusion. .
  • 17. FOOT and ankle  Self reinforced absorbable implants in medial malleolar fractures.  Brunetti et al used bioresorbale implants in the fixation of osteotomies for hallux valgus.  Bioabsorbable implants offer specific advantages in the foot where removal of the hardware is mandatory in some fixations like syndesmotic disruptions and Lisfranc’s dislocations. .
  • 18. Cipro-screw World’s first antibiotic releasing bioabsorbable fixation device
  • 19. FEATURES OF IMPLANTS  Tensile and flex strength are comparable to titanium plating system ,Plates are easy to adapt with aid of heat pack;  A wide selection of implant sizes an shapes are available  A convenient hex-drive breakaway delivery system simplifies screw placement;
  • 20.  Eliminates growth restriction and implant migration for paediatric craniofacial reconstruction;  Resorbs completely and may eliminate the need for second operation;  Does not induce late stage inflammatory Mreaction.
  • 21.  The headed bioabsorbable tissue anchor has a large thread surface per turn of thread.  As the anchor is turned into bone for engaging cancellous bone, the disk-shaped head engages and anchors the tissue to the bone.
  • 22. DEGRADATION AND ELIMINATION  The implants of polyglycolic acid,polylactic acid or polydiaxonone are completely absorbable within the bone tissue and the new bone is deposited on or within the implant as the degradation proceeds.  The degradation of these polymers occurs 1.Mainly by hydrolysis 2.And to lesser extent through non specific enzymatic action.
  • 23.
  • 24.  Factors which influence the degradation process 1.molecular weight 2.crystallinity 3.Thermal history 4.Geometry Poly-lactic acid copolymers have the slowest rate of degradation(half-life 6months)  The co-polymers of polyglycolyic acid and poly paradiaxonone are much more rapid.  The principal route of elimination is respirationand to lesser exent in urine and faeces.
  • 25. DO U KNOW?  The fact that the interfragmentary compression cannot be achieved with polyester pins or rods should be recognized when the indications for the use of these implants are being considered.  Polyester screws do provide compression of the fracture but are more difficult to insert than the comparable metallic screws.
  • 26.  Only fractures affecting the cancellous bone can be managed effectively with the array of implants currently available.  At the moment the INDICATIONS for the biodegradable implants are 1.Radial head Fracture 2.Wedge fractures of the patella 3.Fractures of the proximal and distal ends of the metatarsals and metacarpals 4.osteochondrosis Dessicans or Osteochondral fractures of the femur condyle.
  • 27. 5.Ankle Fracture 6.Adult capitellum Fracture 7.Displaced elbow fractures in children 8.Distal radius fracture 9.Pediatric fracture 10.Small fractures or osteotomies.
  • 28.  Bioabsorbable meshes are available for acetabular reconstructions.  Bioabsorbable implants are also variously used in cranio maxillo facial surgery and dental surgery.
  • 29. ADVANTAGES 1.No irritation of soft tissue 2.No Osteopenia 3.No need of secondary operation to remove the implants. 4.Useful in pediatric fracture fixation. 5.No interference with the callus formation and fracture healing. 6.Anti-biotic releasing Bioabsorbable screws to reduce implant related infecion.
  • 30. COMPLICATIONS  The unique complication of these implants is the delayed inflammatory reaction or sterile inflammatory foreign body reaction.  The other complications include 1.Failure of fixation 2.Postoperative wound infection
  • 31. CLINICAL PRESENTATION  The clinical presentation of the delayed sterile inflammatory reaction is……  The patient has no local or systemic signs of the problems with the wound in the immediate post-op period.,then a painfulerythematous,fluctuant swelling suddenly develops about the healed wound.  The mean interval between the fixation of fracture and clinical manifesation of reaction is twelve weeks.
  • 32.  A sinus draining the liquid remnants of the implant material often form.  Bacterial cultures of the drainage from the sinuses are negative.
  • 33. DRAWBACKS  1.Fixation achieved with these type of implants is often neither rigid not stable enough to hold the fracture with motion or weight bearing force before union.  2.Cast support and use of cruchtes for lower extremity fractures has been recommended,which limits their further use.  3.Bioabsorbable Implants have excessively low moduli resulting in backing out of screws  4.Poor handling characteristics when compared to metals.
  • 34.  5.The price of 45/50 mm fibre reinforced rod is approximately 15 times that of a metallic cancellous screw.  6.The treatment of diaphyseal fractures of long bones however would necessitate a larger device such as a long plate and intramedullary nail,that has a slow rate of degradation.  Nevertheless the unsolved problem of irritation of soft tissue and of osteopenia beneath metallic plates will continue to simulate research on absorbable implants.
  • 35. FUTURE  Resorbable plates can be covalently linked with compounds such as HRP, IL-2, and BMP-2 and represents a novel protein delivery technique. BMP-2 covalently linked to resorbable plates has been used to facilitate bone healing.  Covalent linking of compounds to plates represents a noveL method for delivering concentrated levels of growth factors to a specific site and potentially extending their half-life.  An area for future development would have to focus developing implants that degrade at the “medium term”. Since the screw that persists in its track for 5 years or more does not offer the advantage of bioresorbability.