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Bioabsorbable Implants in Orthopaedic Surgery

 

Definition

  • Bioabsorbable implants are materials that gradually degrade within the body, are absorbed, and are ultimately excreted after fulfilling their intended function.

Introduction

  • Internal fixation implants for fractures are generally required only temporarily, until fracture union occurs.
  • Metallic implants often necessitate a second surgical procedure for removal, which involves:
    • Additional patient discomfort
    • Increased financial cost
    • Risk of operative complications
  • To overcome these disadvantages, biodegradable and bioabsorbable implants were developed.
  • These implants gradually degrade once their mechanical role is completed, eliminating the need for removal surgery.

Problems Associated with Metallic Implants

  • Local soft tissue irritation
  • Chronic pain
  • Release of metallic ions
  • Increased risk of infection
  • Requirement of a second surgery for implant removal
  • These limitations have driven the increasing use of biodegradable implants.

Historical Background

  • In eighteen ninety-three, low molecular weight polyglycolic acid was synthesized by Bischoff and Walden.
  • In nineteen sixty-two, the first synthetic absorbable suture was developed from polyglycolic acid by American Cyanamid Company.
  • In nineteen seventy-five, a ninety to ten copolymer of glycolide and lactide known as polygalactin nine ten was introduced as a commercial absorbable suture.
  • Polyglycolide and polylactide sutures have been used for decades with no reported carcinogenic, teratogenic, toxic, or allergic effects.
  • In nineteen sixty-nine, the use of polyglycolic acid for reinforcing pins, screws, and plates in bone surgery was first proposed.

Materials Used for Bioabsorbable Implants

  • Polyglycolic acid
  • Polylactic acid
  • Polydioxanone
  • Self-reinforced polymers
  • Polylactide co-glycolide
  • Polycaprolactone

Characteristics of an Ideal Biomaterial

  • Does not provoke inflammatory or toxic reactions
  • Completely metabolized after fulfilling its function
  • Leaves no residual trace in the body
  • Easily manufactured into the required implant form
  • Has an acceptable shelf life
  • Can be sterilized effectively

Polyglycolic Acid

  • First material used to produce a fully synthetic absorbable suture
  • Highly crystalline and insoluble in most solvents
  • Exhibits high tensile strength and stiffness
  • Loses approximately fifty percent of strength within two weeks
  • Loses full strength by four weeks
  • Completely absorbed within four to six months

Polylactic Acid

  • Exists in two optical isomers:
    • D-polylactide
    • L-polylactide
  • L-polylactide is the naturally occurring form.
  • A blend of D and L polylactide is known as DL-polylactide.

Mechanical Properties and Applications

  • Polyglycolic acid and crystalline polylactic acid:
    • High tensile strength
    • Low elongation
    • Suitable for weight-bearing fixation devices and sutures
  • DL-polylactide:
    • Low tensile strength
    • High elongation
    • Used mainly as a drug delivery system

Other Bioabsorbable Polymers

  • Polycaprolactone:
    • Degradation time of approximately two years
    • Copolymers are used in monofilament sutures
  • Polyanhydrides:
    • Excellent biocompatibility
    • Degradation time adjustable from days to years
    • Primarily used for drug delivery
  • Polyorthoesters:
    • Used as drug delivery systems

Mechanism of Degradation

  • After implantation, the material must remain intact until healing is achieved.
  • Degradation occurs gradually through chemical hydrolysis of unstable molecular bonds.
  • Degraded products are absorbed and excreted by the body.

Types of Degradation

Bulk Degradation in Semicrystalline Polymers

  • Occurs in two phases:
    • Water penetrates the implant and attacks chemical bonds in the amorphous regions
    • Long polymer chains break into shorter fragments
    • Enzymatic degradation of fragments follows
  • Occurs when water penetration exceeds the rate of polymer dissolution.

Surface Erosion

  • Water penetrates the implant more slowly than polymer breakdown.
  • Degradation occurs layer by layer at the surface.

Clinical Applications of Bioabsorbable Implants

Knee Surgery

  • Widely used in anterior cruciate ligament reconstruction as:
    • Interference screws
    • Transfixation screws
  • Osteochondral fractures can be fixed arthroscopically using biodegradable pins.
  • Meniscal fixation devices and biodegradable suture anchors allow advanced soft tissue reconstruction in complex knee injuries.

Shoulder Surgery

  • Used in repair and reconstruction of:
    • Rotator cuff tears
    • Shoulder instability
    • Biceps tendon lesions
  • Suitable for labral repair and biceps tendon tenodesis.
  • Clinical studies show comparable outcomes between polyglycolic acid and polylactic acid implants at two-year follow-up.
  • Eliminates the need for bone tunnels in many procedures.

Spine Surgery

  • Early clinical studies demonstrated use as interbody spacers in lumbar fusion.
  • Implants persisted longer than the expected twelve to eighteen months.
  • Clinical and radiographic results support use in transforaminal lumbar interbody fusion.
  • Comparative animal studies showed superior distraction, stiffness, and fusion with bioabsorbable composite cages.
  • Bioabsorbable anterior cervical plates demonstrated stability comparable or superior to resorbable mesh systems.

Paediatric Orthopaedics

  • Suitable for fixation of growth plate fractures.
  • Studies show comparable results to metallic implants in paediatric elbow fractures.
  • Self-reinforced polylactic acid screws provide sufficient fixation in subtalar arthrodesis.
  • Described applications include olecranon fracture fixation in children.

Foot and Ankle Surgery

  • First use in ankle fracture fixation reported in nineteen eighty-five.
  • Applications include:
    • Medial malleolar fractures
    • Talar fractures
    • Intra-articular osteochondral fractures
  • Used in fixation of:
    • Hallux valgus osteotomies
    • Syndesmotic injuries
    • Lisfranc joint dislocations

Hand and Wrist Surgery

  • Mini-plate systems available for:
    • Fracture fixation
    • Osteotomies
    • Arthrodesis
  • Typically use self-reinforced polylactide plates with small-diameter screws.

Additional Applications

  • Used in fixation of fractures involving:
    • Humeral condyle
    • Distal radius and ulna
    • Radial head
  • Bioabsorbable meshes available for acetabular reconstruction.
  • Widely used in:
    • Craniofacial surgery
    • Maxillofacial surgery
    • Dental surgery

Advantages of Bioabsorbable Implants

  • No long-term soft tissue irritation
  • No stress shielding or osteopenia
  • No requirement for implant removal surgery
  • Particularly useful in paediatric fracture fixation
  • Do not interfere with callus formation or fracture healing
  • Can act as carriers for local drug delivery, including antibiotics

Limitations and Drawbacks

  • Lower stiffness compared to metallic implants
  • Higher cost
  • Risk of fixation failure
  • Lower elastic modulus leading to screw back-out

Complications

  • Delayed sterile inflammatory or foreign body reaction
  • Painful, erythematous, fluctuant swelling over healed surgical sites
  • Average onset approximately twelve weeks after implantation
  • Failure of fixation
  • Postoperative wound infection

Conclusion

  • Bioabsorbable implants represent an important advancement in orthopaedic fixation.
  • They reduce the need for secondary surgery and associated complications.
  • Proper material selection and indication are critical for success.
  • Continued improvements in material science may further expand their role in orthopaedic practice.

 

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