One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

May 19, 2026 updated by: OrthoCarolina Research Institute, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

343

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopaedics at Rush University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institue
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years following surgery
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.
2 years following surgery
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.
2 years following surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 2 years
Death within two years of surgical treatment for periprosthetic joint infection.
2 years
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).
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Collaborators

University of Iowa
The Cleveland Clinic
Emory University
University of Southern California
University of California, San Francisco
Vanderbilt University
Carilion Clinic
University of Utah
Hospital for Special Surgery, New York
Ochsner Health System
Cleveland Clinic Florida
Rothman Institute at Thomas Jefferson University
Midwest Orthopaedics Rush University Medical Center

Investigators

  • Principal Investigator: Thomas K Fehring, MD, Attending Hip & Knee Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 7, 2026

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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