Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint

Can Two-stage Primary Total Knee Arthroplasty With Low-dose Antibiotics Effectively Treat Septic Arthritis of the Native Knee Joint?

Septic arthritis (SA) of the native knee joint is rare but difficult to manage. Open or arthroscopic debridement is currently the most widely used approach. The problem is that there is a 71% and 50% chance of requiring revision surgery, respectively. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures. Investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA and evaluated its efficacy.

Study Overview

• Status: Completed
• Conditions: Septic Arthritis
• Intervention / Treatment: Procedure: two-stage primary total knee arthroplasty with low-dose antibiotics

Detailed Description

Septic arthritis (SA) of the native knee joint is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9 per 100,000. The treatment is challenging and the ideal treatment strategy is not well established. Over the past decades, open or arthroscopic debridement with systemic antibiotic therapy is the most widely used approach. However, a recent study has shown that these two methods have a failure rate as high as 50%-71%. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures.

A few reports proposed two-stage exchange to address SA and showed satisfying clinical outcomes. Orthopedic surgeons removed the infected soft and bone tissue during the first operation and then implant antibiotic-loaded bone cement spacer. Once the infection had been addressed, a new prosthesis was inserted in a second operation. This approach could greatly boost the success rate to over 95%. However, the issue is that high-dose antibiotics bone cement may cause life-threatening complications such as acute kidney injury and drug-induced immune hemolytic anemia. Therefore, investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA.

Investigators summarized and analyzed the treatment processes and performed laboratory, imaging, and functional evaluations after treatment. The purpose was to introduce a new treatment regimen for SA and evaluate the technical points of the regimen, and prognosis over medium-term follow-ups.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 300001
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with SA based on one or more of the following: clinical presentations (fever, joint pain, restricted mobility, swelling and redness, and/or a discharging sinus communicating with the joint); elevated inflammation markers; evidence of infection on images; purulence in the joint, and positive frozen section or cultures
• Without infections at other sites
• Without venous thrombosis of the lower limbs
• American society of Anesthesiologists (ASA) physical status classification was either 1 or 2
• With complete data for the main indicators (routine blood test results, C-reactive protein level, erythrocyte sedimentation rate, X-ray and/or MRI scans of the surgical site, and the Knee Society Function scores).

Exclusion Criteria:

• Patients (<60 yrs) without progression to advanced osteoarthritis
• In poor general condition who could not tolerate surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All the patients; patients received two-stage primary total knee arthroplasty with low-dose antibiotics

Procedure: two-stage primary total knee arthroplasty with low-dose antibiotics; Briefly, investigators completely debrided all necrotic soft tissue in the first stage of the operation. The surgical site was flushed twice with hydrogen peroxide, iodine, and saline solutions. Then, the antibiotic-loaded cement spacer was inserted. After surgery, a 10-day course of intravenous organism-specific antibiotics or vancomycin was administered, followed by oral antibiotic therapy. Second-stage reimplantation was performed once there was no sign of infection. The spacer was removed and the new prosthesis was implanted without the use of antibiotic-containing bone cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	The clearance rate of infection	two years postoperatively
Surgical success rate	The clearance rate of infection	three years postoperatively
Surgical success rate	The clearance rate of infection	four years postoperatively
Surgical success rate	The clearance rate of infection	five years postoperatively
Surgical success rate	The clearance rate of infection	six years postoperatively
Surgical success rate	The clearance rate of infection	seven years postoperatively
Surgical success rate	The clearance rate of infection	eight years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in knee joint function	record Knee Society Function scores (0-100), the higher the score, the better the function	baseline, 1 month, 2 month, 3 month, 6 month, and yearly postoperatively

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Lan Tang, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Publications and helpful links

General Publications

• Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.
• Mathews CJ, Weston VC, Jones A, Field M, Coakley G. Bacterial septic arthritis in adults. Lancet. 2010 Mar 6;375(9717):846-55. doi: 10.1016/S0140-6736(09)61595-6.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 31, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Arthritis, Infectious; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2022-0292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No