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Year

General

2010

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade. Surgeon knowledge of tissue bank practices in donor consent and screening, infectious disease testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks, benefits and alternatives of using allograft tissue. Tissue recalls have occurred but hospitals were unable to identify all recipients or determine final disposition of the recalled tissue. This handout provides viewpoints that support a paradigm change. Imagine a national, real-time web-based system that contains a database for donor and allograft registries with systems built in that enhances widespread communication when an adverse event/reaction occurs. If participation by stakeholders is high, immediate identity of tissue that has been recalled could be realized at the hospital and an allograft not inadvertently used before official notification of recall is sent. Compliance by end users to such a web-based system would eliminate the need for completion and mailing of tissue usage cards (see The Joint Commission, Transplant Safety Chapter at Standard TS.03.02.01, EP 7.)

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2010

The Evolving Role of Bone-Graft Substitutes

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

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2010

Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Brief Description

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

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2009

Orthopaedic Infection Prevention and Control: An Emerging New Paradigm

Brief Description

More than 65 million inpatient and outpatient surgeries are done each year at U.S. hospitals. The Centers for Disease Control and Prevention (CDC) estimate that the rates of surgical site infection (SSI) range from 2% – 3% of uninfected cases – actual rates, however, are probably higher. SSIs are associated with: 38% of all surgical-related nosocomial infections; other wound complications; 60% higher risk of an intensive care unit (ICU) stay; five times greater risk of readmission; a two- to three-fold higher risk of death; and Staphylococcus aureus most often.

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2009

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

View PDF

2009

Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Brief Description

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

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2008

Orthopaedic Infection: Community-Associated and Healthcare-Associated MRSA

Brief Description

Methicillin-resistant Staphylococcus aureus (MRSA) is a strain of the staph infection resistant to beta-lactam antibiotics (penicillin, oxacillin, amoxicillin, and methicillin). MRSA is a bacterium commonly carried on the skin or in the nose of healthy people who generally do not exhibit any symptoms. The CDC reports that an estimated 25 – 30% of the population is colonized with Staph and only 1% with MRSA; meaning, the bacteria is present, but not causing an infection. MRSA presents in two different environments: Community Associated MRSA (CA-MRSA) and Healthcare Associated MRSA (HA-MRSA).

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2008

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor consent and screening, infectious disease testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks, benefits, and alternatives of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2008

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

View PDF

2008

Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Brief Description

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

View PDF

2007

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor gifting and screening, serology testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks and benefits of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2007

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

View PDF

2006

The Influence of Antibiotics on the Fatigue Life of Acrylic Bone Cement: Assuring Clinical Structural Integrity

Brief Description

Aseptic loosening attributed to cement fracture and the subsequent disruption of fixation interfaces remains a major long-term failure mode of cemented arthroplasty. Knowledge of the fracture strength of bone cement, especially in fatigue, is an important indicator of cement integrity and the potential for fixation failure. In current practice, orthopaedic surgeons may choose to utilize antibiotics in bone cement for prophylaxis or treatment of a known infection. However, the antibiotics, bone cements and mixing methodologies employed lead to variability in the quality of the end product. To date, several orthopaedic manufacturers received Food and Drug Administration (FDA) 510[k] clearance for their pre-packaged antibiotic-loaded bone cement for use in the second stage of a two-stage revision situation where the initial infection has been cleared. This availability provides a more uniform cement mix with known mechanical and elution characteristics at the 0.5 to 1.0g level of antibiotic per 40g of polymer powder. This study evaluated the influence of antibiotic inclusion on the porosity, strength and fatigue life of six contemporary bone cements.

View PDF

2006

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone replacement materials. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives.

View PDF

2006

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade. Surgeon knowledge of tissue bank practices in donor consent and screening, serology testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks, benefits and alternatives of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2005

Highly Crosslinked Polyethylenes: Hopes vs. Realities

Brief Description

The enduring success of the low-friction arthroplasty first advanced by Sir John Charnley as a solution for severe hip arthritic problems may be appreciated from the fact that in 2003 more than 800,000 hip and knee arthroplasties were performed in the United States. The prevalence of aseptic loosening attributed to ultra-high molecular weight polyethylene (UHMWPE) debris-induced osteolysis has been in the single digits in most contemporary series, with some reports describing prostheses surviving for 20 to 30 years and represents the gold standard against which contemporary material improvements will be measured over time. Beginning in 1997, the FDA approved a series of UHMWPE’s with elevated crosslinking for use in prosthetic joints. Their stated benefit is to dramatically decrease the generation of UHMWPE wear debris, confirmation of which finds support in wear simulator reports for hip and knee components. The commercial adaptation of these new UHMWPE’s has been aggressively marketed particular to acetabular components well in advance of now emerging short-term clinical reports. What follows is a descriptor of the clinical evolution of UHMWPE bearing surfaces: the good, the bad and the hopeful.

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2005

Antibiotic-Loaded Bone Cement in Aseptic Total Joint Replacement: Whys, Wherefores & Caveats

Brief Description

Deep wound infection following joint replacement is one of the most devastating complications facing both the physician and patient. The use of antibiotic-loaded bone cement (ALBC) is a well-accepted adjunct for treatment of an established infection. However, its use for prophylaxis in the prevention of infection remains controversial in North America. Since the 1970’s, the use of ALBC in Europe has been extremely widespread as a method of prophylaxis in both primary and aseptic revision joint replacement surgery. This handout presents available data which supports the efficacy of ALBC as a method of infection prevention in joint replacement.

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2005

The Influence of Antibiotics on the Fatigue Life of Acrylic Bone Cement: Assuring Clinical Structural Integrity – Series II

Brief Description

Aseptic loosening attributed to cement fracture and the subsequent disruption of fixation interfaces remains a major long-term failure mode of cemented arthroplasty. Knowledge of the fracture strength of bone cement, especially in fatigue, is an important indicator of cement integrity and the potential for fixation failure. In current practice, orthopaedic surgeons may choose to utilize antibiotics in bone cement for prophylaxis or treatment of a known infection. However, the antibiotics, bone cements and mixing methodologies employed lead to variability in the quality of the end product. To date, several orthopaedic manufacturers have received Food and Drug Administration (FDA) 510[k] clearance for their pre-packaged antibiotic-loaded bone cement for use in the second stage of a two-stage revision situation where the initial infection has been cleared. This availability provides a more uniform cement mix with known mechanical and elution characteristics at the 0.5 to 1.0g level of antibiotic per 40g of polymer powder. This study evaluates the influence of antibiotic inclusion on the porosity, strength and fatigue life of six contemporary bone cements.

View PDF

2004

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor gifting and screening, serology testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks and benefits of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2004

Antibiotic-Loaded Bone Cement in Aseptic Total Joint Replacement: Whys, Wherefores & Caveats

Brief Description

Deep wound infection following joint replacement is one of the most devastating complications facing both the physician and patient. The use of antibiotic-loaded bone cement (ALBC) is a well-accepted adjunct for treatment of an established infection. However, its use for prophylaxis in the prevention of infection remains controversial in North America. Since the 1970’s, the use of ALBC in Europe has been extremely widespread as a method of prophylaxis in both primary and aseptic revision joint replacement surgery. This handout presents available data, which supports the efficacy of ALBC as a method of infection prevention in joint replacement.

View PDF

2004

The Influence of Antibiotics on the Fatigue Life of Acrylic Bone Cement: Assuring Clinical Structural Integrity

Brief Description

Aseptic loosening attributed to cement fracture and the subsequent disruption of fixation interfaces remains a major long-term failure mode of cemented arthroplasty. Knowledge of the fracture strength of bone cement, especially in fatigue, is an important indicator of cement integrity and the potential for fixation failure. In current practice, orthopaedic surgeons may choose to utilize antibiotics in bone cement for prophylaxis or treatment of a known infection. However, the antibiotics, bone cements and mixing methodologies employed lead to variability in the quality of the end product. During 2003, several orthopaedic manufacturers received Food and Drug Administration (FDA) 510[k] clearance for their pre-packaged antibiotic-loaded bone cement for use in the second stage of a two-stage revision situation where the initial infection has been cleared. This availability provides a more uniform cement mix with known mechanical and elution characteristics at the 0.5 to 1.0g level of antibiotic per 40g of polymer powder. This study evaluated the influence of antibiotic inclusion on the porosity, strength and fatigue life of Surgical Simplex P bone cement when employing both vacuum and hand mixing technologies.

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2003

New Polys for Old: Contribution or Caveat?

Brief Description

The enduring success of the low-friction arthroplasty first advanced by Sir John Charnley as a solution for severe hip arthritic problems may be appreciated from the fact that in 2001 more than 600,000 hip and knee arthroplasties were performed in the United States. The prevalence of aseptic loosening attributed to polyethylene debris-induced osteolysis has been in the single digits in most contemporary series, with some reports describing prostheses surviving for 20 to 30 years. Despite this obvious success, polyethylene debris is increasingly identified as the principle causative factor of bone loss and failure of TJA procedures. The conditions of occurrence, severity and clinical consequences suggest limitations on the in vivo integrity of contemporary arthroplasty designs. Material remedies inclusive of carbon reinforced polyethylene (Poly II), heat pressing and Hylamer with its variants have been advanced as alternatives with negative clinical results. Contemporary attempts to improve longevity (i.e., post-processing heat stabilization, peroxide additives and increased radiation with remelting) focus on the benefit of increased cross-linking while minimizing free radical creation. With increasing patient longevity and activity levels a search for the ultimate polymer is important. Variations on an already successful theme hope to lead to its optimization in this century. However, these “new polys” offer no direct clinical evidence to demonstrate their efficacy. It is known that reprocessing techniques will alter mechanical characteristics. Contemporary improvements in laboratory evaluative capabilities suggest significant reduction in component wear, but past experiences, in these regards, have not always predicted their clinical viability.

View PDF

2003

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of Musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor gifting and screening, serology testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks and benefits of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2003

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone-substitute materials. These graft alternatives have varying degrees of regulatory scrutiny and thus their true safety and effectiveness in patients may not be know prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives. This handout provides an update of an emerging class of bone-graft substitutes, which have found application as osteoconductive fixation and structural media.

View PDF

2003

Antibiotic-Loaded Bone Cement in Aseptic Total Joint Replacement: Whys, Wherefores & Caveats

Brief Description

Deep wound infection following joint replacement is one of the most devastating complications facing both the physician and patient. The use of antibiotic-loaded bone cement (ALBC) is a well-accepted adjunct for treatment of an established infection. However, its use for prophylaxis in the prevention of infection remains controversial in North America. Since the 1970’s, the use of ALBC in Europe has been extremely widespread as a method of prophylaxis in both primary and aseptic revision joint replacement surgery. This handout presents available data, which supports the efficacy of ALBC as a method of infection prevention in joint replacement.

View PDF

2003

Assuring Cement Fixation: All Mixing Systems are NOT the Same

Brief Description

Aseptic loosening attributed to cement fracture and the subsequent disruption of fixation interfaces remains a major long-term failure mode of cemented arthroplasty. Knowledge of the fracture strength of bone cement, especially in fatigue, is an important indicator of cement integrity and the potential for fixation failure. Several manufacturers have advocated mixing devices to increase the strength of bone cement by reducing its porosity or pore diameter. This study evaluates different mixing methodologies as they influence cement porosity and the diametral tensile strength of cement specimens in both single cycle and fatigue. This serves as a means of establishing the effectiveness of these methods in producing optimal bone cement for use in joint arthroplasty.

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2002

New Polys for Old: Contribution or Caveat?

Brief Description

The enduring success of the low-friction arthroplasty first advanced by Sir John Charnley as a solution for severe hip arthritic problems may be appreciated from the fact that in 2000 more than 600,000 hip and knee arthroplasties were performed in the United States. The prevalence of aseptic loosening attributed to polyethylene debris-induced osteolysis has been in the single digits for most contemporary series, with some reports describing prostheses surviving for 20 to 30 years. Despite this obvious success, polyethylene debris is increasingly identified as the principle causative factor of bone loss and failure of TJA procedures. The conditions of occurrence, severity and clinical consequences suggest limitations on the in vivo integrity of contemporary arthroplasty designs. Material remedies inclusive of carbon reinforced polyethylene (Poly II), heat pressing and Hylamer with its variants have been advanced as alternatives with negative clinical results. Contemporary attempts to improve longevity (i.e., post-processing heat stabilization, peroxide additives and increased radiation with remelting) focus on the benefit of increased cross-linking while minimizing free radical creation. With increasing patient longevity and activity levels a search for the ultimate polymer is important. Variations on an already successful theme hope to lead to its optimization in this century. However, these “new polys” offer no direct clinical evidence to demonstrate their efficacy. It is known that reprocessing techniques will alter mechanical characteristics. Contemporary improvements in laboratory evaluative capabilities suggest significant reduction in component wear, but past experiences, in these regards, have not always predicted their clinical viability.

View PDF

2002

Musculoskeletal Allograft Tissue Safety

Brief Description

The use of Musculoskeletal allograft tissue in reconstructive orthopaedic procedures has markedly increased over the last decade, Surgeon knowledge of tissue bank practices in donor gifting and screening, serology testing and processing is important when making the decision to use these allograft tissues. The orthopaedic surgeon also has the responsibility to inform the patient about the risks and benefits of using allograft tissue. This handout provides an overview of some of these issues.

View PDF

2002

Alternative Bearing Surfaces: The Good, Bad & Ugly

Brief Description

The enduring success of the low-friction arthroplasty advanced by Sir John 2000, more than 270,000 hip arthroplasties were performed in the United States. Over the last three decades, patient profiles have changed substantially, resulting in demands for a greater service life of ultra-high molecular weight polyethylene (UHMWPE) hip components. Material failure, often leading to an osteolytic response, is increasingly associated with younger, more active patients. In this context, the low-friction solution has become a problem, limiting in vivo system longevity and initiated a reexamination of alternative bearing surfaces. This presentation summarizes current clinical solutions to long-term bearing articulation involving metal-polyethylene, metal-metal, ceramic-polyethylene and ceramic-ceramic alternatives. Clinical and laboratory evidences are presented which describe the efficacy and concerns of these bearing couples as well as their current availability through the FDA regulatory process.

View PDF

2002

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

It is estimated that more than 500,000 bone-grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone-substitute materials. These graft alternatives have varying degrees of regulatory scrutiny and thus their true safety and effectiveness in patients may not be known prior to their use by orthopaedic surgeons. It is thus important to gain insight into this emerging class of bone-substitute alternatives. This handout provides an update of an emerging class of bone-graft substitutes, which have found application as osteoconductive fixation and structural media.

View PDF

2001

Alternative Bearing Surfaces: The Good, Bad & Ugly

Brief Description

The enduring success of the low friction arthroplasty advanced by Sir John Charnley as a solution for hip problems may be appreciated by the fact that in 1999, over 270,000 hip arthroplasties were performed in the United States. Over the last three decades, patient profiles have substantially changed resulting in a greater service life demand on UHMWPE hip components. Material failure, often leading to osteolytic response is increasingly associated with younger, more active patients. In this context, the low friction solution has become a problem limiting in vivo system longevity and initiated a reexamination of alternative bearing surfaces. This presentation summarizes current clinical solutions to long-term bearing articulation involving metal-polyethylene, metal-metal, ceramic-polyethylene and ceramic-ceramic alternatives. Clinical and laboratory evidences are presented which describe the efficacy and concerns of these bearing couples as well as their current availability through the FDA regulatory process.

View PDF

2001

New Polys for Old: Contribution or Caveat?

Brief Description

The enduring success of the low friction arthroplasty first advanced by Sir John Charnley as a solution for severe hip arthritic problems may be appreciated from the fact that in 1999 over 500,000 hip and knee arthroplasties were performed in the United States. The percentage of aseptic loosening attributed to polyethylene debris-induced osteolysis is in the single digits for most contemporary series with some reports describing 20 to 30 year patient survivals. Despite this obvious success, polyethylene debris is increasingly identified as the principle causative factor of bone loss and failure of TJA procedures. The conditions of occurrence, severity and clinical consequences suggest limitations on the in vivo integrity of contemporary arthroplasty designs. Material remedies inclusive of carbon reinforced polyethylene (Poly II), heat pressing and Hylamer with its variants have been advanced as alternatives with negative clinical results. Contemporary attempts to improve longevity (i.e., post-processing heat stabilization, peroxide additives and increased radiation with remelting) focus on the benefit of increased cross-linking while minimizing free radical creation. With increasing patient longevity and activity levels a search for the ultimate polymer is important. Variations on an already successful theme hope to lead to its optimization in this century. However, these “new polys” offer no direct clinical evidence to demonstrate their efficacy. It is known that reprocessing techniques will alter mechanical characteristics. Contemporary improvements in laboratory evaluative capabilities suggest significant reduction in component wear, but past experiences, in these regards, have not always predicted their clinical viability.

View PDF

2001

Bone Graft Substitutes: Facts, Fictions & Applications

Brief Description

Estimates of over 500,000 bone grafting procedures are performed annually in the United States, with approximately half of these procedures related to spine fusion. These numbers easily double on a global basis and indicate a shortage in the availability of musculoskeletal donor tissue traditionally used in these reconstructions. This reality has stimulated a proliferation of corporate interest in supplying what is seen as a growing market in bone substitute materials. These graft alternatives have varying degrees of regulatory scrutiny and thus, their true safety and effectiveness in patients may not be known prior to their use by orthopaedic surgeons. It is thus, important to gain insight into this emerging class of bone substitute alternatives. This handout provides an update of an emerging class of bone graft substitutes, which have found application as osteoconductive fixation and structural media.

View PDF