Clinical trial NCT02734134: One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
Official title: One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Keywords: Periprosthetic joint infection
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Hospital for Special Surgery, New York
name: Rothman Institute at Thomas Jefferson University
name: Midwest Orthopaedics Rush University Medical Center
name: Vanderbilt University
name: Emory University
name: University of Iowa
name: Carilion Clinic
name: University of Southern California
name: Ochsner Health System
name: Cleveland Clinic Florida
name: University of Utah
name: University of California, San Francisco
First posted: 2016-04-12
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of infection
timeFrame: 1 year following treatment
Secondary outcomes:
measure: Health Related Quality of Health
timeFrame: 2 years following surgery
measure: Patient-Reported Functional Outcomes
timeFrame: 2 years following surgery
measure: Patient-Reported Functional Outcomes
timeFrame: 2 years following surgery
Other outcomes:
measure: Death
timeFrame: 2 years
measure: Percentage of patients requiring surgical revision for causes other than infection
timeFrame: Two years
Locations:
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Research Institue
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Attending Hip & Knee Surgeon
name: Thomas K Fehring, MD
role: PRINCIPAL_INVESTIGATOR
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