Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.

Study Overview
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Brief Summary
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To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

Detailed Description
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Since joint replacement procedures have been successful in recent decades, every year the number of implanted prostheses is increasing, however, at the same time, orthopaedic surgeons also find complications inherent to this surgery, where peri-prosthetic infection results to be the most devastating. In order to find a solution to this terrible complication, prophylactic and therapeutic measures have been implemented, emerging techniques where the application of local antibiotics in the surgical site has turned out to be a promising concept. It has been shown that the non-modifiable risk factors of patients undergoing joint replacement surgery increase the risk of infection rate. Therefore, the identification of risk factors, decolonization and the prophylactic administration of antibiotics allow an effective reduction of periprosthetic infection. In order to reduce and, as far as posible, avoid periprosthetic infections in participants undergo knee or hip joint replacement with non-modifiable risk factors, the prophylactic use of calcium sulphate loaded with antibiotic for local application is proposed.

Official Title
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Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections

Conditions
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Infection

Intervention / Treatment
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* Device: Antibiotic local prophylaxis with medicated calcium sulfate beads
* Procedure: Classical parenteral antibiotic prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with fracture or osteoarthrosis of the hip or knee that require treatment by joint replacement. patients who have any of the Non-Modifiable Risk Factors prior to surgery or during transoperative period. Patients entitled to the ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y Municipios) Exclusion Criteria: Patients that lose their validity of institutional rights and do not follow up Patients who die during the study due to other causes not related to the orthopedic procedure. Patients who do not have any of the risk factors for periprosthetic infection Patients allergic to vancomycin or ceftriaxone.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial. Study participants are randomly assigned to one of two groups: the experimental group receiving the Calcium sulfate beds with antibiotics and a comparison group (control) which receives a conventional prophylactic therapy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium sulfate Group<br>Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement | Device: Antibiotic local prophylaxis with medicated calcium sulfate beads<br>* Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection<br>* Other names: Hip or Knee Joint Replacement;|
| Active Comparator: Control Group<br>Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement | Procedure: Classical parenteral antibiotic prophylaxis<br>* Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection<br>* Other names: Hip pr Knee Joint Replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partipants Achieving a Lower Hip or Knee Periprosthetic Joint Infection Rate With Local Versus Conventional Intravenous Antibiotic Prophilaxys, Measured With CRP, ERS in Serum and Sinovial Fluid Leukocytes , Over the 12-week Observation Period. | Acute periprosthetic knee or hip infection was determined using CRP and ESR serum biomarkers, which are the most commonly published serum biomarkers in periprosthetic joint infection literature. The cut off point for CRP was considered 93mg/L and 44mm/hr for ESR. The serum biomarker sample was taken and evaluated on day 5 and weeks 4, 8 and 12. Leukocytes in synovial fluid are among the criteria for definition of periprosthetic joint infection with a cut off point above 12,800 cells/µL and were only included if serum biomarkers were elevated. | Day 5, Weeks 4, 8, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay as an Indicator of the Hospital Economic Burden | The length of stay is an important indicator of efficiency and hospital economic burden. The reduction in number of hospitalization days results in lower risk of infection and less medication side effects and decreased need of hospital supplies. The difference in the average days of hospitalization between both groups indirectly represents the economic cost spent by the hospital. | Surgical procedure day to hospital discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periprosthetic Joint Infection, Prophylaxis, Joint Replacement, Calcium Sulfate Beads