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

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

343 Participants Needed

Trial Summary

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.

What data supports the effectiveness of one-stage and two-stage exchange joint replacement surgery for joint replacement infections?

Research shows that one-stage exchange surgery can be as effective as two-stage surgery for treating joint infections, especially when the infection is caused by bacteria that are not resistant to antibiotics. One-stage surgery is also less costly and allows patients to regain mobility faster compared to the two-stage approach. ^{1 2 3 4 5}

Is one-stage or two-stage joint replacement surgery safe for treating infections?

Both one-stage and two-stage joint replacement surgeries are generally considered safe for treating joint infections. Two-stage surgery is often used for more difficult cases and is safe but involves more time and cost. One-stage surgery is also safe and may be better for patients with fewer health issues. ^{1 2 5 6 7}

How does one-stage exchange joint replacement surgery differ from two-stage exchange surgery for joint infections?

One-stage exchange joint replacement surgery is unique because it involves removing the infected joint and replacing it with a new one in a single operation, which can reduce hospital stays and improve mobility compared to the traditional two-stage approach that requires two separate surgeries with a period of limited mobility in between. ^{1 3 5 7 8}

What is the purpose of this trial?

The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.

Research Team

Thomas K Fehring, MD

Principal Investigator

Attending Hip & Knee Surgeon

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

References

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

One-stage exchange arthroplasty for chronic periprosthetic hip infection: results of a large prospective cohort study. [2016]

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

Risk Factors for Failure After 1-Stage Exchange Total Knee Arthroplasty in the Management of Periprosthetic Joint Infection. [2021]

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

Is 2-Stage Septic Revision Worth the Money? A Cost-Utility Analysis of a 1-Stage Versus 2-Stage Septic Revision of Total Knee Arthroplasty. [2023]

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

Defining Treatment Success After 2-Stage Exchange Arthroplasty for Periprosthetic Joint Infection. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The treatment of periprosthetic joint infection: safety and efficacy of two stage versus one stage exchange arthroplasty. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Exchange arthroplasty for infected knee replacements. A new two-stage method. [2020]

7. France pubmed.ncbi.nlm.nih.gov

A comparison of short term complication rate between 44 two- and 385 one-stage septic exchange arthroplasties in chronic periprosthetic joint infections. [2021]

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

One-stage revision for infected shoulder arthroplasty: prospective, observational study of 37 patients. [2023]