Polymers in Orthopaedic Surgery


Designation

Title

F451-08

Standard specification for Acrylic Bone Cement

F639-09

Standard specification for Polyethylene Plastics for medical applications

F648-14

Standard specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for surgical implants

F755-99(2011)

Standard specification for selection of Porous Polyethylene for use in surgical implants

F1925-09

Standard specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for surgical implants

F2026-14

Standard specification for Polyetheretherketone (PEEK) Polymers for surgical implant applications

F2033-12

Standard specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Materials Made of Metallic, Ceramic, and Polymeric Materials

F2313-10

Standard specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for surgical implants with mole fractions greater than or equal to 70 % Glycolide

F2565-13

Standard guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for surgical implant applications

F2579-10

Standard specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for surgical implants

F2695-12

Standard specification for ultra-high molecular weight Polyethylene Powder Blended with Alpha-Tocopherol (Vitamin E) and Fabricated Forms for surgical implant applications

F2759-11

Standard guide for assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) used in Orthopedic and Spinal Devices

F2820-12

Standard specification for Polyetherketoneketone (PEKK) Polymers for surgical implant applications

F2902-12

Standard guide for assessment of Absorbable Polymeric Implants





Nonabsorbable Polymers



Polymethylmethacrylate


Otto Rohm is credited with the development of perhaps the most widely used polymer in orthopaedic surgery—poly(methylmethacrylate) (PMMA)—in 1901 [1] but the material did not come into widespread use in orthopaedics until Sir John Charnley described its use for bonding prostheses to bone in the early 1960s [2]. A good review of the early work in characterizing PMMA including the evolution of the use in orthopaedics can be found in the article by Dennis Smith where he describes his collaboration with Charnley [3].

PMMA is composed of a powder polymer and a liquid monomer, which is usually mixed in a 2:1 ratio just prior to implantation. The liquid monomer is mainly (approximately 97 %) methylmethacrylate, but also contains an accelerator and a stabilizer [4]. The composition of the powder component varies by brand but contains mainly microspheres of ground PMMA or copolymer with small amounts of radiopaque substances and an initiator. Some formulations also contain a dye or antibiotics. Mixing of the polymer and the monomer creates an exothermic reaction, which can have a necrotic effect on surrounding musculoskeletal tissues. The resulting polymer will progress through several stages during curing, usually reaching a workable, dough-like consistency within a few minutes followed by the hardening phase where peak temperatures are reached. There is a published standard that describes the required characteristics of all acrylic bone cements including setting time, material properties, and maximum temperature of polymerization (Table 5.1).

PMMA is strongest in compression and weakest in tension and under shear stresses with the ultimate compressive strength lying between trabecular and cortical bone [5]. The addition of antibiotics to the cement, commonly done to prevent or treat infections, can significantly impair the strength of the cement [5, 6]. There are numerous other factors that can affect the mechanical properties of PMMA including molecular weight, mixing method, and sterilization [711].

Despite its widespread and successful use, relatively rare complications have been documented with the use of PMMA in orthopaedic surgery. Tissue necrosis can be caused by the high heat of polymerization or by the chemicals themselves [12, 13]. Bone cement implantation syndrome (BCIS) is usually associated with total hip arthroplasty and can be fatal for the patient. Clinical manifestations include hypoxia, hypotension, cardiac arrhythmias and in some cases cardiovascular collapse [14]. Extravasation of the cement from the site of implantation can lead to a so-called “cement emboli”, which although rare is a potentially fatal complication. [1518] The cement can fail mechanically, leading to loosening of the implant it is meant to stabilize [5, 19, 20] or osteolysis due to the accumulation of wear particulates [21].


Polyethylene


After PMMA, the most commonly used polymer in orthopaedic surgery is polyethylene (PE). For several decades, this material has been the gold standard for bearing surfaces in total joint replacement devices. In general, the type of PE used in total joint replacements is ultra-high molecular weight polyethylene (UHMWPE) or highly cross-linked polyethylene (HXPE) [22]. Implant bearing surfaces are usually machined from ram-extruded bar stock, and then packaged and sterilized prior to shipment. Table 5.2 includes a list of some of the types of stock PE used by orthopaedic implant manufacturers.


Table 5.2
Sample of commercially available polymer products used in orthopaedic surgery


















































































































































































































































































Company

Product type/trade name

Polymer type

Polymer detail

Arthrex

Interference screws

Bioabsorbable

PLLA

Arthrex

Interference screws

Bioabsorbable

70 % PLDLA 30 % Biphasic Calcium Phosphate

Arthrex

Interference screws

Nonabsorbable

PEEK

Arthrex

Tenodesis screws

Bioabsorbable

PLLA

Arthrex

Tenodesis screws

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

Tenodesis screws

Nonabsorbable

PEEK

Arthrex

Transfix

Bioabsorbable

PLLA

Arthrex

Transfix

Bioabsorbable

70 % PLDLA 30 % Biphasic Calcium Phosphate

Arthrex

Graftbolt

Bioabsorbable

70 % PLDLA 30 % Biphasic Calcium Phosphate

Arthrex

Graftbolt

Nonabsorbable

PEEK

Arthrex

Compression screw

Bioabsorbable

PLLA

Arthrex

Corkscrew

Bioabsorbable

PLDLA

Arthrex

Corkscrew FT

Bioabsorbable

PLLA

Arthrex

Corkscrew FT

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

PushLock

Bioabsorbable

PLLA

Arthrex

PushLock

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

PushLock

Nonabsorbable

PEEK

Arthrex

SwiveLock

Bioabsorbable

PLLA

Arthrex

SwiveLock

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

SwiveLock

Nonabsorbable

PEEK

Arthrex

FASTak

Bioabsorbable

PLDLA

Arthrex

SutureTak

Bioabsorbable

PLDLA

Arthrex

SutureTak

Bioabsorbable

PLLA

Arthrex

SutureTak

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

SutureTak

Nonabsorbable

PEEK

Arthrex

SwiveLock tenodesis

Bioabsorbable

85 % PLLA 15 % β-Tricalcium Phosphate

Arthrex

SwiveLock tenodesis

Nonabsorbable

PEEK

BioMet

Active articulation™ Dual mobility hip

Nonabsorbable

E1® Antiosidant infused PE

DePuy Synthes

Plivios revolution cage for posterior lumbar interbody dusion (PLIF)

Nonabsorbable

PEEK

Medtronic

Prevail cervical interbody device

Nonabsorbable

PEEK

Medtronic

Bryan cervical disc

Nonabsorbable

Polyurethane

Small Bones Innovations

STAR™ ankle

Nonabsorbable

UHMWPE

Small Bones Innovations

rHead™ recon

Nonabsorbable

UHMWPE

Small Bones Innovations

RE-MOTION™ total Wrist

Nonabsorbable

UHMWPE

Small Bones Innovations

Avanta CMC

Nonabsorbable

UHMWPE

Smith & Nephew

Healicoil regenesorb

Bioabsorbable

PLGA, β-TCP, Calcium Sulfate

Stryker

Mobile bearing hip™ system

Nonabsorbable

Polyethylene

Stryker

X3 bearing

Nonabsorbable

Polyethylene

Stryker

Crossfire polyethylene

Nonabsorbable

Polyethylene

Stryker

Solar shoulder

Nonabsorbable

UHMWPE

Stryker

Biosteon® Wedge interference screw

Bioabsorbable

25 % Hydroxyapatite (HA), 75 % amorphous PLLA

Stryker

Bioabsorbable interference screw

Bioabsorbable

PLLA

Stryker

BioZip absorbable anchor

Bioabsorbable

PLLA

Stryker

Intraline, Zip, Twinloop, ReelXAnchors

Nonabsorbable

PEEK

Stryker

AVS AL spacer system

Nonabsorbable

PEEK

Synthes

ProDisc

Nonabsorbable

Polyethylene

Zimmer

Conventional polyethylene

Nonabsorbable

GUR 1050 polyethylene resin or bar stock

Zimmer

Sulene®

Nonabsorbable

GUR 1020 polyethylene bar stock

Zimmer

Prolong® Highly crosslinked polyethylene

Nonabsorbable

GUR 1050 polyethylene bar stock

Zimmer

Longevity® Highly crosslinked polyethylene

Nonabsorbable

GUR 1050 polyethylene bar stock

Zimmer

Durasul® Highly crosslinked polyethylene

Nonabsorbable

GUR 1050 polyethylene bar stock/pre-forms

Zimmer

Vivacit-E® Vitamin E highly crosslinked polyethylene

Nonabsorbable

GUR 1020 polyethylene resin, VitE

The method of sterilization has critical effects on the mechanical properties of PE. Sterilization using gamma radiation produces free-radicals. If oxygen is present, the free-radicals produce chain scission and significant degradation of the mechanical strength of the implant. On the other hand, gamma irradiation without the presence of oxygen results in cross-linking of the polymer chains and can produce implants with improved wear properties [22, 23]. The addition of vitamin E, a natural antioxidant, is also thought to counteract the oxidative degradation of PE, and currently there are commercially-available PE implants containing vitamin E [24].

One of the greatest concerns about the use of PE in joint replacement bearing surfaces is the wear of the material and the effect the wear debris has on the surrounding tissues. For many years, it has been demonstrated that this wear debris leads to osteolysis and loosening of the prosthetic components [21, 25]. Wear of the polyethylene or loosening of the implants, which may be related to wear debris, remains a common reason for revision surgery after total hip [26, 27] or total knee arthroplasty [28].

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Mar 26, 2017 | Posted by in GENERAL & FAMILY MEDICINE | Comments Off on Polymers in Orthopaedic Surgery

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