One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
- Conditions
- Surgical Site Infection
- Interventions
- Procedure: One-stage exchange joint replacement surgeryProcedure: Two-stage exchange joint replacement surgery
- Registration Number
- NCT02734134
- Lead Sponsor
- OrthoCarolina Research Institute, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 343
-
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)
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Patients with a previous irrigation and debridement for periprosthetic infection
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Culture negative infections whereby the infecting organism has not identified
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Patients with systemic sepsis who require emergent surgery
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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
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HIV positive patients or patients on chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-stage exchange One-stage exchange joint replacement surgery One surgery where the infected implants are removed and the hip or knee joint are 'washed out' before new joint replacement implants are re-implanted during the same surgical procedure. Two-stage exchange Two-stage exchange joint replacement surgery Two surgeries; during the first surgery the infected implants are removed and a spacer is placed in the hip or knee joint in place of the implants. A second surgery to re-implant the hip or knee joint replacement implants is performed if and when the infection has cleared.
- Primary Outcome Measures
Name Time Method Recurrence of infection 1 year following treatment The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).
- Secondary Outcome Measures
Name Time Method Health Related Quality of Health 2 years following surgery All patients will complete the Veteran's Rand - 12 (VR-12) which is a general health measure. The VR-12 also yields a health utility measure that can be used to calculate quality-adjusted life years in an economic cost-utility analysis.
Patient-Reported Functional Outcomes 2 years following surgery Knee patients will complete the Knee injury and Osteoarthritis Outcome Score (KOOS) Junior which is a region-specific measure of pain and function of the knee.
Trial Locations
- Locations (5)
Midwest Orthopaedics at Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
OrthoCarolina Research Institue
🇺🇸Charlotte, North Carolina, United States
Rothman Institute at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States