← Back to Search

One-Stage vs Two-Stage Surgery for Joint Replacement Infections

N/A
Waitlist Available
Led By Thomas K Fehring, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

Study Summary

This trial will compare two common treatments for periprosthetic joint infection (PJI), an infection around an artificial knee or hip.

Who is the study for?
This trial is for adults over 18 with chronic infection in their artificial knee or hip, who've had previous cleaning surgery and meet specific infection criteria. They must speak English and consent to participate. Excluded are those with systemic sepsis, acute infections, fungal or resistant infections not treatable by certain antibiotics, HIV patients, chemotherapy patients, and cases with extensive soft tissue damage.Check my eligibility
What is being tested?
The study compares two surgical methods for treating joint infections around artificial knees or hips: one-stage exchange (replacing the infected joint once) versus two-stage exchange (removing the infected joint and then replacing it later).See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as bleeding, blood clots, persistent infection at the site of surgery, pain at the implant site, limited range of motion post-surgery and possibly a need for additional surgeries if initial treatment fails.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a chronic infection in my knee or hip replacement.
Select...
I had surgery to clean an infection around my artificial joint.
Select...
I speak English and am willing to sign the consent form.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence of infection
Secondary outcome measures
Health Related Quality of Health
Patient-Reported Functional Outcomes
Other outcome measures
Death
Communicable Diseases

Trial Design

2Treatment groups
Active Control
Group I: One-stage exchangeActive Control1 Intervention
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.
Group II: Two-stage exchangeActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkOTHER
242 Previous Clinical Trials
61,559 Total Patients Enrolled
Rothman Institute at Thomas Jefferson UniversityUNKNOWN
Midwest Orthopaedics Rush University Medical CenterUNKNOWN

Media Library

One-stage exchange joint replacement surgery Clinical Trial Eligibility Overview. Trial Name: NCT02734134 — N/A
Surgical Site Infection Research Study Groups: One-stage exchange, Two-stage exchange
Surgical Site Infection Clinical Trial 2023: One-stage exchange joint replacement surgery Highlights & Side Effects. Trial Name: NCT02734134 — N/A
One-stage exchange joint replacement surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT02734134 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots available to participate in this medical investigation?

"According to clinicaltrials.gov, this research venture is still actively looking for participants. This trial was initially published on May 18th 2016 and the most recent update occurred on March 31st 2022."

Answered by AI

What is the sample size for this research endeavor?

"To complete this medical study, 308 suitable participants will be needed. These can enroll at various approved locations such as Cleveland Clinic in Ohio and Hospital for Special Surgery in New york City."

Answered by AI

How many healthcare establishments are currently carrying out this clinical exploration?

"Five medical sites are running this trial, located in Cleveland, New york and Chicago with two additional locations. To minimize travel demands on participants it is advised to select the nearest clinic."

Answered by AI
Recent research and studies
~39 spots leftby Mar 2025