Septic ArthritisNCT05484284
Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint
A study testing two-stage primary total knee arthroplasty with low-dose antibiotics in people with Septic Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- two-stage primary total knee arthroplasty with low-dose antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2022to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients (<60 yrs) without progression to advanced osteoarthritis
- In poor general condition who could not tolerate surgery
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 300001
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Arthritis
- Being tested
- two-stage primary total knee arthroplasty with low-dose antibiotics
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-stage primary total knee arthroplasty with low-dose antibioticsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| All the patients | Experimental | patients received two-stage primary total knee arthroplasty with low-dose antibiotics Receives: Procedure: two-stage primary total knee arthroplasty with low-dose antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
The clearance rate of infection
Measured: two years postoperatively
Surgical success rate
The clearance rate of infection
Measured: three years postoperatively
Surgical success rate
The clearance rate of infection
Measured: four years postoperatively
Surgical success rate
The clearance rate of infection
Measured: five years postoperatively
Surgical success rate
The clearance rate of infection
Measured: six years postoperatively
Surgical success rate
The clearance rate of infection
Measured: seven years postoperatively
Surgical success rate
The clearance rate of infection
Measured: eight years postoperatively
Secondary outcomes (1)
change from baseline in knee joint function
record Knee Society Function scores (0-100), the higher the score, the better the function
Measured: baseline, 1 month, 2 month, 3 month, 6 month, and yearly postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start22 Feb 2022
- Primary completion6 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Tang, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484284
- Sponsor's protocol ID
- 2022-0292
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28366221Mathews 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.
PubMed 20206778
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Two-stage Primary Total Knee Arthroplasty With Low-dose Antibiotics Effectively Treat Septic Arthritis of the Native Knee Joint?
- ClinicalTrials.gov ID
- NCT05484284
- Acronym / sponsor ID
- 2022-0292
- Conditions
- Septic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the patients | Experimental | Procedure: two-stage primary total knee arthroplasty with low-dose antibioticspatients received two-stage primary total knee arthroplasty with low-dose antibiotics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients (<60 yrs) without progression to advanced osteoarthritis
- In poor general condition who could not tolerate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-stage primary total knee arthroplasty with low-dose antibioticsBriefly, 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. | Procedure or surgery | All the patients |
Primary outcome
Surgical success rate
Time frame: two years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: three years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: four years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: five years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: six years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: seven years postoperatively
The clearance rate of infection
Surgical success rate
Time frame: eight years postoperatively
The clearance rate of infection
1 secondary outcome
change from baseline in knee joint function
Time frame: baseline, 1 month, 2 month, 3 month, 6 month, and yearly postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 28366221Ross 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.
- Background: PubMed 20206778Mathews 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Tang, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two-stage primary total knee arthroplasty with low-dose antibiotics in people with Septic Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: two years postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484284, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.