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Which surgery works best for infected hip or knee replacements?

NCT ID NCT02734134

Knowledge-focused Sponsor: OrthoCarolina Research Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 343 adults with infections in their artificial hip or knee joints. It compared two common surgeries: one-stage (removing and replacing the joint in one operation) and two-stage (removing the joint, treating the infection, then replacing it later). The main goal was to see which approach better prevents the infection from coming back within a year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

343 people

The number who actually took part.

Started

May 2016

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgical site infection

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Midwest Orthopaedics at Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • OrthoCarolina Research Institue

    Charlotte, North Carolina, 28207, United States

  • Rothman Institute at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.