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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 belowSelect...
I have a chronic infection in my knee or hip replacement.
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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic infection in my knee or hip replacement.I had surgery to clean an infection around my artificial joint.I cannot have my wound properly closed if I undergo a one-stage exchange due to extensive soft tissue involvement.I have a recent joint infection or am HIV positive or undergoing chemotherapy.I speak English and am willing to sign the consent form.I am older than 18 years.I need urgent surgery due to a severe infection in my body.
Research Study Groups:
This trial has the following groups:- Group 1: One-stage exchange
- Group 2: Two-stage exchange
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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
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