Single vs Double Debridement for Joint Infections After Prosthetics

Recruiting at 1 trial location

Overseen By Ben Mallinger, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Chronic PJI, Revision surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 weeks

490 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Planned Double Debridement, Antibiotics and Implant Retention for joint infections after prosthetics?

Research shows that a two-stage debridement approach with implant retention has a high success rate, with one study reporting a 90% success rate in controlling infections. Additionally, surgical debridement combined with antibiotics is appealing as it can lead to infection eradication while retaining the implant, especially in acute infections. ^{1 2 3 4 5}

Is the treatment of debridement with antibiotics and implant retention generally safe for humans?

The treatment of debridement with antibiotics and implant retention is generally considered safe, as it avoids major surgery and has been used successfully in many patients with joint infections. However, there is a risk of losing the implant in some cases, especially in late infections. ^{2 3 5 6 7}

How does the Planned Double Debridement, Antibiotics and Implant Retention treatment differ from other treatments for joint infections after prosthetics?

This treatment is unique because it involves a planned second debridement (cleaning out of infected tissue) in addition to antibiotics and implant retention, which may lead to higher success rates in retaining the implant compared to a single debridement. Traditional treatments often involve only one debridement, and the two-stage approach has shown promising results in managing acute infections. ^{1 2 3 5 7}

What is the purpose of this trial?

The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).

Research Team

Matthew Abdel, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have a recent infection in my knee or hip replacement.

Exclusion Criteria

I have had revision surgery or a two-stage reimplantation before.

I have had joint infection symptoms for more than 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either single or planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, followed by IV antibiotics and oral suppressive antibiotics

Approximately 2 weeks

In-hospital stay for surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of clinical outcome scores and adverse events

1 year

Regular follow-up visits

Long-term follow-up

Participants are monitored for long-term outcomes, including reoperation rates and survivorship

10 years

Treatment Details

Interventions

• Planned Double Debridement, Antibiotics and Implant Retention
• Single Debridement, Antibiotics and Implant Retention

Trial Overview 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.

Participant Groups

Group I: Single DAIR Surgery Arm Active Control 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of Debridement for Early Periprosthetic Joint Infection after Hip Arthroplasty. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Two-Stage Debridement With Prosthesis Retention for Acute Periprosthetic Joint Infections. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Implant retention in infected joint replacements: a surgeon's perspective. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Pathogen-driven decision for implant retention in the management of infected total knee prostheses. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Does a 2-Stage Debridement Result in Higher Rates of Implant Retention Compared With Single Debridement Alone? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Second Surgical Debridement for Acute Periprosthetic Joint Infections Should Not Be Discarded. [2021]

7. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Is DAIR Still an Effective Way to Eradicate Acute Prosthetic Joint Infections? Our Experience in the Jordanian Royal Medical Services. [2022]