An interventional study of two-stage primary total knee arthroplasty with low-dose antibiotics in Septic Arthritis, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Arthritis, Infectious; 25 are open to participants now.
This study's enrollment of 14 is below the median of 41 across 48 interventional studies indexed under Arthritis, Infectious.
Browse Arthritis, Infectious studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
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.
Surgical success rate
The clearance rate of infection
Time frame: two years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: three years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: four years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: five years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: six years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: seven years postoperatively
Surgical success rate
The clearance rate of infection
Time frame: eight years postoperatively
change from baseline in knee joint function
record Knee Society Function scores (0-100), the higher the score, the better the function
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, and yearly postoperatively
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, Zhejiang University, School of Medicine