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

Not currently recruiting at 4 trial locations

Overseen By Susan M Odum, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Disqualifiers: Systemic sepsis, Fungal infections, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies depending on treatment type

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for treating infections around artificial knee or hip joints. One-stage exchange joint replacement surgery replaces the infected joint in a single procedure, while two-stage exchange joint replacement surgery requires two separate surgeries. The trial aims to determine which approach more effectively manages joint infections. Individuals with persistent infections around knee or hip replacements, especially those who have already undergone surgery to clean the area, might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to important research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for this trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that one-stage exchange joint replacement surgery is generally safe. One study found a low death rate of 0.6% for this method. However, there is a risk that the infection might not be completely cleared, leading to ongoing infection.

In contrast, two-stage exchange surgery is more effective at controlling infections but presents its own challenges. This method often results in more complications and sometimes requires additional surgeries to address problems. The death rate for this option is higher at 11.5%.

Both treatments have their pros and cons. One-stage surgery is less likely to result in death but might not fully clear the infection. Two-stage surgery is more effective at dealing with infections but can lead to more issues and a higher risk of death. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring one-stage and two-stage exchange surgeries for joint replacement infections because each approach offers distinct potential benefits. The one-stage exchange is unique because it involves only a single surgery, where the infected implants are removed and replaced with new ones in the same procedure, potentially reducing recovery time and hospital stays compared to traditional methods. The two-stage exchange, while more conventional, provides thorough infection control by using a spacer until the infection clears, followed by implanting new joints. This trial aims to determine which method provides better outcomes, ultimately helping to refine treatment strategies for joint infections.

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

This trial will compare one-stage and two-stage joint replacement surgeries for treating joint infections. Studies have shown that one-stage joint replacement surgery has a lower death rate of 0.6% compared to 11.5% for the two-stage approach, suggesting that one-stage surgery might be safer for survival. However, some research indicates that two-stage surgeries may be more successful at treating joint infections, potentially making them more effective at eliminating the infection. Both methods have similar rates of reinfection, indicating that each has its strengths. Specifically, two-stage surgeries clear the infection in about 77% of cases, but they can lead to more complications and require additional surgeries. Both methods have their pros and cons, and the choice may depend on individual patient factors. ^{1 2 4 6 7}

Who Is on the Research Team?

Thomas K Fehring, MD

Principal Investigator

Attending Hip & Knee Surgeon

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I had surgery to clean an infection around my artificial joint.

I am older than 18 years.

Exclusion Criteria

Culture negative infections whereby the infecting organism has not identified

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a one-stage or two-stage exchange arthroplasty for the management of chronic PJI

Varies depending on treatment type

Follow-up

Participants are monitored for recurrence of infection and other outcomes

1 year

Extended Follow-up

Participants are assessed for health-related quality of life and functional outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• One-stage exchange joint replacement surgery
• Two-stage exchange joint replacement surgery

Trial Overview 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).

How Is the Trial Designed?

Group I: One-stage exchange Active Control 1 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 exchange Active Control 1 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.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Hospital for Special Surgery, New York

Collaborator

Trials

257

Recruited

61,800+

Rothman Institute at Thomas Jefferson University

Collaborator

Trials

1

Recruited

340+

Midwest Orthopaedics Rush University Medical Center

Collaborator

Trials

1

Recruited

340+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Carilion Clinic

Collaborator

Trials

85

Recruited

15,400+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5220180/

One-stage Exchange Arthroplasty for Periprosthetic Hip ... Mid to long-term results after treatment of 118 cases of periprosthetic infections after knee joint replacement using one-stage exchange surgery. Orthopade ...

2. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/joint-infection-mortality-after-knee-replacement-surpasses-common-cancers

Joint Infection Mortality After Knee Replacement - Consult QD One-stage exchange: 0.6% mortality (95% CI: 0-3.4); Two-stage exchange: 11.5% mortality (95% CI: 8.0-15.5). Advertisement. In a subgroup ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02734134

One Stage Versus Two Stage For Periprosthetic Hip And ... The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11068120/

A Meta-Analysis of Success Rates of One-Stage Versus ... Two-stage revisions are associated with higher success rates than one-stage revisions in the treatment of knee PJIs.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0976566224001000

Single-stage revision in the management of prosthetic joint ... [Mid- to long-term results after treatment of 118 cases of periprosthetic infections after knee joint replacement using one-stage exchange surgery]. Orthopä ...

6. orthobullets.com orthobullets.com/recon/5004/prosthetic-joint-infection

Prosthetic Joint Infection - Recon higher risk of continued infection from residual microorganisms. outcomes. variable success of 75-100%. two-stage replacement arthroplasty.

7. link.springer.com link.springer.com/article/10.1007/s43465-025-01405-6

Single-Stage Revision for Treatment of Prosthetic Joint ... This review highlights the growing role of single-stage revision as a viable and cost effective approach for managing PJI in carefully selected patients.