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One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

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ClinicalTrials.gov Identifier: NCT02734134
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
The Cleveland Clinic
Hospital for Special Surgery, New York
Rothman Institute at Thomas Jefferson University
Midwest Orthopaedics Rush University Medical Center
Vanderbilt University
Emory University
University of Iowa
Carilion Clinic
University of Southern California
Ochsner Health System
Cleveland Clinic Florida
University of Utah
University of California, San Francisco
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Procedure: One-stage exchange joint replacement surgery Procedure: Two-stage exchange joint replacement surgery Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
Actual Study Start Date : May 18, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: One-stage exchange
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.
 Procedure: One-stage exchange joint replacement surgery
Active Comparator: Two-stage exchange
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.
 Procedure: Two-stage exchange joint replacement surgery


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence of infection [ Time Frame: 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 :
  1. Health Related Quality of Health [ Time Frame: 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.

  2. Patient-Reported Functional Outcomes [ Time Frame: 2 years following surgery ]
    Hip patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS), Junior which is a region-specific measure of pain and function of the hip.

  3. Patient-Reported Functional Outcomes [ Time Frame: 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.


Other Outcome Measures:
  1. Death [ Time Frame: 2 years ]
    Death within two years of surgical treatment for periprosthetic joint infection.

  2. Percentage of patients requiring surgical revision for causes other than infection [ Time Frame: Two years ]
    Revision of prosthetic joint for causes other than infection (e.g. hematoma, spacer dislocation).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734134


Contacts
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Contact: Susan M Odum, PhD 704-323-2265 susan.odum@orthocarolina.com
Contact: Christi Cadd, MBA 704-323-2260 christi.cadd@orthocarolina.com

Locations
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United States, Illinois
Midwest Orthopaedics at Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Craig Della Valle, MD    877-632-6637      
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Michael B Cross, MD    212-606-1000      
United States, North Carolina
OrthoCarolina Research Institue Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, PhD    704-323-2265    susan.odum@orthocarolina.com   
Contact: Christi Cadd, MBA    704-323-2260    christi.cadd@orthocarolina.com   
Principal Investigator: Thomas K. Fehring, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Carlos Higuera, MD    216-444-2606      
United States, Pennsylvania
Rothman Institute at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Javad Parvizi, MD    800-321-9999      
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
The Cleveland Clinic
Hospital for Special Surgery, New York
Rothman Institute at Thomas Jefferson University
Midwest Orthopaedics Rush University Medical Center
Vanderbilt University
Emory University
University of Iowa
Carilion Clinic
University of Southern California
Ochsner Health System
Cleveland Clinic Florida
University of Utah
University of California, San Francisco
Investigators
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Principal Investigator: Thomas K Fehring, MD Attending Hip & Knee Surgeon
More Information
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Publications:

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02734134    
Other Study ID Numbers: 1106
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by OrthoCarolina Research Institute, Inc.:
Periprosthetic joint infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
 Wound Infection
Postoperative Complications
Pathologic Processes