Single vs Double Debridement for Joint Infections After Prosthetics

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgeries for treating infections in hip or knee replacements. It compares single and double debridement surgeries, both followed by antibiotics, to determine which more effectively clears infections while preserving the implant. Suitable candidates have had a hip or knee replacement and show early signs of infection, such as redness or a non-healing wound. Participants will undergo either one or two surgeries, along with antibiotics, which are standard treatments for these infections. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance treatment options for future patients.

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 prior data suggests that these surgical methods are safe for treating joint infections after prosthetics?

Research has shown that both single and double debridement, antibiotics, and implant retention (DAIR) are generally well-tolerated treatments for joint infections after hip and knee replacements. Studies have found similar success rates for both single and double DAIR procedures, with single DAIR successful about 67% of the time and double DAIR about 70%. This indicates that both methods effectively treat infections.

DAIR works best when performed soon after surgery. Although there is a risk of infection recurrence, these procedures are standard practices and have been used for many years, indicating safety for most patients. However, success can vary depending on factors such as the timing of the procedure and a person's overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether a planned double debridement procedure is more effective than the standard single debridement for treating joint infections after prosthetic surgeries. The key difference lies in the frequency of the surgical procedure: the double debridement involves two rounds of surgery, which might improve infection control and patient outcomes. By comparing these two approaches, the trial aims to determine if the double debridement could provide a better standard of care, potentially leading to faster recovery and fewer complications for patients with prosthetic joint infections.

What evidence suggests that this trial's treatments could be effective for joint infections after prosthetics?

This trial will compare single versus double debridement, along with antibiotics and keeping the implant in place (known as DAIR), for treating infections around joint replacements in the hip and knee. Research has shown that both single and double DAIR manage these infections. One study found similar success rates for double and single DAIR, with success rates of about 70% and 67%, respectively. Both methods can effectively manage sudden infections. Specifically, single DAIR resolved infections in 73.9% of knee cases and 58.3% of hip cases when treated early. Acting quickly often leads to better results. ^{1 6 7 8 9}

Who Is on the Research Team?

Matthew Abdel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488757/

Clinical outcomes of an unplanned second debridement ... Debridement, antibiotic therapy, and implant retention (DAIR) is the most frequently recommended strategy for managing acute PJI, offering ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11519117/

Success rate of single versus multiple debridement ... This study suggests that double DAIR is a valid treatment option for acute PJI after TKA and THA, with a success rate comparable to single DAIR (70% vs. 67%, p ...

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(25)00654-0/abstract

Efficacy of DAIR (Debridement, Antibiotics, and Implant ... Further analysis revealed significant variation in failure rates depending on the timing of the infection: 34.2% (95% CI: 28.8 to 39.6) for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1198743X25002198

Debridement, antibiotics and implant retention: are all ... The success rate of DAIR is reported to vary between 11.1% and 100% in 4897 PJIs [2]. Consequently, the indications for DAIR and its outcome differ worldwide [3] ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05640336

Treatment of Acute Periprosthetic Joint Infection ... Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely ...

6. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)01318-4/fulltext

Outcomes of Debridement, Antibiotics, and Implant ... DAIR after four weeks had an increased risk of subsequent revision, and older women undergoing early DAIR interventions had more favorable outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10929323/

Contemporary outcomes of debridement, antibiotics and ... This review discusses outcomes of DAIR for knee PJI, published over the last two decades. Keywords: Knee; arthroplasty; infection; periprosthetic joint ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2059775423005588

DAIR for Early Prosthetic Joint Infection: Systematic Review DAIR is an overall successful treatment for early post-operative and acute hematogenous PJIs in hip and knee prostheses.

9. link.springer.com link.springer.com/article/10.1007/s00590-024-04091-6

Success rate of single versus multiple debridement ... This study suggests that double DAIR is a valid treatment option for acute PJI after TKA and THA, with a success rate comparable to single DAIR (70% vs. 67%, p ...