Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint
Primary Purpose
Septic Arthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
two-stage primary total knee arthroplasty with low-dose antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Septic Arthritis
Eligibility Criteria
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
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All the patients
Arm Description
patients received two-stage primary total knee arthroplasty with low-dose antibiotics
Outcomes
Primary Outcome Measures
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Surgical success rate
The clearance rate of infection
Secondary Outcome Measures
change from baseline in knee joint function
record Knee Society Function scores (0-100), the higher the score, the better the function
Full Information
NCT ID
NCT05484284
First Posted
July 28, 2022
Last Updated
July 31, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05484284
Brief Title
Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint
Official Title
Can Two-stage Primary Total Knee Arthroplasty With Low-dose Antibiotics Effectively Treat Septic Arthritis of the Native Knee Joint?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All the patients
Arm Type
Experimental
Arm Description
patients received two-stage primary total knee arthroplasty with low-dose antibiotics
Intervention Type
Procedure
Intervention Name(s)
two-stage primary total knee arthroplasty with low-dose antibiotics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
two years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
three years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
four years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
five years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
six years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
seven years postoperatively
Title
Surgical success rate
Description
The clearance rate of infection
Time Frame
eight years postoperatively
Secondary Outcome Measure Information:
Title
change from baseline in knee joint function
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Tang, MD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
300001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28366221
Citation
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.
Results Reference
background
PubMed Identifier
20206778
Citation
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.
Results Reference
background
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Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint
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