One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:2/15/2018
Start Date:June 2016
End Date:December 2019
Contact:Susan M Odum, PhD
Email:susan.odum@orthocarolina.com
Phone:704-323-2265

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The purpose of this study is to compare the outcomes of two different treatment options
commonly used to manage periprosthetic joint infection (PJI), an infection around the
artificial knee or hip.

Total joint arthroplasty (TJA) is a very common and successful procedure, and is expected to
become more prevalent in the upcoming years. However, despite its success, TJA is associated
with some complications, including periprosthetic joint infection (PJI). PJI is a devastating
complication that is associated with marked patient morbidity and mortality and is an immense
economic burden. Although the rate of PJI following a TJA is low, the burden is rising
exponentially due to health complications and treatment costs. There are two common types of
surgical treatments that can be used to treat chronic PJI, a two-stage exchange arthroplasty
and a one-stage exchange arthroplasty. During a two-stage exchange arthroplasty, the implants
are removed, infected tissues are debrided and a temporary antibiotic impregnated spacer
fashioned from polymethylmethacrylate is placed (stage one). Afterwards the patient undergoes
many weeks of intravenous antibiotics, followed by reimplantation at a later date (stage
two). During the time between the first and second stage of the revision patients are often
immobile, experience severe pain due to a lack of functioning joint, and may experience
systemic toxicity associated with the administration of antibiotics. In a one stage exchange
arthroplasty, the infected prosthesis is removed, infected tissues are debrided, and a new
prosthesis is reimplanted during the same procedure.

While the two-stage exchange arthroplasty is the preferred method of treatment for chronic
PJI in North America, the one-stage exchange arthroplasty is the method of choice in Europe
and some centers have reported comparable results in terms of success for one-stage exchange
to two-stage exchange arthroplasty. However, there has been no randomized, prospective,
controlled study to date that compares one-stage exchange to two-stage exchange arthroplasty.
Because of the lack of comparative outcome reports, and the perceived higher rate of failure
of one-stage exchange arthroplasty, surgeons in North America prefer to perform the
traditional two-stage exchange arthroplasty for management of chronic PJI. Several teams have
succeeded in performing a one-stage exchange arthroplasty in selected patients, but this
procedure has not gained much popularity in the US.

The purpose of this study is to investigate the outcome of one-stage and two-stage exchange
arthroplasty for the management of patients with chronic PJI. The hypothesis of this study is
that one-stage exchange arthroplasty, if performed in the appropriate patient population,
carries a similar success rate for the treatment of chronic PJI as two-stage exchange
arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.

Inclusion Criteria:

- Patients >18 years old

- Patients who speak English and are willing to sign the consent form

- Patients with chronic infection of a total knee or total hip arthroplasty, defined as:

- A sinus communicating with the prosthesis

- Two positive cultures obtained from the prosthesis

- 3 of 5 criteria: (i) Elevated erythrocyte sedimentation rate (ESR) (>30mm/jr) and
c-reactive protein (CRP) (>10mg/L) (ii) Elevated synovial leukocyte count (>3000
cells/µL) or change of ++ on leukocyte esterase strip (iii) Elevated synovial
neutrophil percentage (>80%) (iv) One positive culture (v) Positive histological
analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high
power fields x400)

- Patients with a previous irrigation and debridement for periprosthetic infection

Exclusion Criteria:

- Culture negative infections whereby the infecting organism has not identified

- Patients with systemic sepsis who require emergent surgery

- Patients with extensive soft tissue involvement that would preclude the closure of the
wound after reimplantation, if the patient were to undergo the one-stage exchange

- Patients with acute PJI or acute hematogenous PJI, defined as:

- Presentation of systems <4 weeks from index procedure

- Presentation of systems <4 week duration

- Fungal infections

- Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or
heat stable antibiotic additives to bone cement with documented elution
characteristics

- Revision surgery or previous two-stage reimplant

- HIV positive patients or patients on chemotherapy
We found this trial at
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Chicago, Illinois 60605
Phone: 877-632-6637
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-2606
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Charlotte, North Carolina 28207
Principal Investigator: Thomas K. Fehring, MD
Phone: 704-323-2265
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535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: 212-606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Philadelphia, Pennsylvania 19107
Phone: 800-321-9999
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Philadelphia, PA
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