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Single vs Double Debridement for Joint Infections After Prosthetics

N/A

Waitlist Available

Led By Matthew Abdel, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 5, and 10 years following dair procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial studies two different surgical treatments for joint infections after hip and knee replacements. Comparing single to double debridement, antibiotics, and implant retention.

Who is the study for?

This trial is for English-speaking patients with a recent infection around their hip or knee joint replacement. They must have certain lab results indicating an infection, like positive cultures from the prosthesis or high levels of inflammation markers in blood and tissue. It's not open to those who've had revision surgery or chronic infections lasting more than 4 weeks.

What is being tested?

Researchers are comparing two surgeries for treating joint infections after hip or knee replacements: one involves a single cleaning procedure while the other uses two planned cleanings. Both include keeping the implant in place and using antibiotics afterwards.

What are the potential side effects?

Potential side effects may include reactions to anesthesia, complications from surgical procedures such as bleeding or further infection, and adverse responses to long-term antibiotic use which can range from stomach upset to more serious conditions like antibiotic resistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 5, and 10 years following dair procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 5, and 10 years following dair procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 5, and 10 years following dair procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subjects free from failure

Secondary study objectives

1-year surgical reoperation rate

10-year surgical revision rate

5-year surgical reoperation rate

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Single DAIR Surgery ArmActive Control1 Intervention

Subjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.

Group II: Double DAIR Surgery ArmActive Control1 Intervention

Subjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.

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