The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial

2014-07-23 21:09:56 | BioPortfolio


Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. Current controversy about the use of ABC exists around the world. Without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent to which ABC compared to regular cement reduces the infection rate in patients over the first two years following TKA and, 2) the resource use implications associated with the use of ABC for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. All patients will be administered IV antibiotics immediately prior to surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. A blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. Blinded radiologists will interpret the 2 year series of radiographs for each patient. We will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. This study includes a full economic analysis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention




Simplex™ P with Tobramycin, Simplex™ P


London Health Sciences Centre, University Hospital
N6A 5W9


Not yet recruiting


University of Western Ontario, Canada

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:56-0400

Clinical Trials [483 Associated Clinical Trials listed on BioPortfolio]

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of a...

SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal i...

Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study

Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong painful...

Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study

: Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong painf...

Herpes Simplex Type 1 Suppression in Hepatitis C

The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to he...

PubMed Articles [6313 Associated PubMed Articles listed on BioPortfolio]

Pediatric Ophthalmoplegia and Ptosis in Epidermolysis Bullosa Simplex Associated With Muscular Dystrophy.

Oculomotor dysfunction in epidermolysis bullosa simplex associated with muscular dystrophy has been reported rarely in the ophthalmic literature. In a series of 6 patients with epidermolysis bullosa s...

Illustrated redescription of the male of Ixodes simplex Neumann, 1906.

Ixodes simplex is a tick species of bats, mainly reported from Schreibers' Bent-winged bat, Miniopterus schreibersii, all over its host's range. While being a common parasite of cave-dwelling bat spec...

The lack of association between herpes simplex virus 1 or Toxoplasma gondii infection and cognitive decline in the general population: An 11-year follow-up study.

Inflammation has been suggested to be one, possibly treatable, cause of cognitive decline and dementia. The purpose of the present article was to investigate whether the herpes simplex virus 1 (HSV-1)...

Decompressive craniectomy as salvage treatment in herpes simplex encephalitis: two case reports.

Herpes simplex encephalitis is a rare disease with significant morbidity and mortality, although targeted therapy is widely available. We present two cases of herpes simplex encephalitis in previously...

Epidermolysis bullosa simplex generalized severe induces a Th17 response and is improved by Apremilast treatment.

Epidermolysis bullosa simplex generalized severe is a genetic disorder caused by mutation in KRT5 or KRT14 genes. Usually considered as a mechanical disease, recent data argue for additional inflammat...

Medical and Biotech [MESH] Definitions

A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.)

Trans-acting protein that combines with host factors to induce immediate early gene transcription in herpes simplex virus.

A cellular transcriptional coactivator that was originally identified by its requirement for the stable assembly IMMEDIATE-EARLY PROTEINS of the HERPES SIMPLEX VIRUS. It is a nuclear protein that is a transcriptional coactivator for a number of transcription factors including VP16 PROTEIN; GA-BINDING PROTEIN; EARLY GROWTH RESPONSE PROTEIN 2; and E2F4 TRANSCRIPTION FACTOR. It also interacts with and stabilizes HERPES SIMPLEX VIRUS PROTEIN VMW65 and helps regulate GENETIC TRANSCRIPTION of IMMEDIATE-EARLY GENES in HERPES SIMPLEX VIRUS.

A form of epidermolysis bullosa characterized by serous bullae that heal without scarring. Mutations in the genes that encode KERATIN-5 and KERATIN-14 have been associated with several subtypes of epidermolysis bullosa simplex.

Infection of the genitals (GENITALIA) with HERPES SIMPLEX VIRUS in either the males or the females.

More From BioPortfolio on "The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial"

Quick Search


Relevant Topics

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Searches Linking to this Trial