Clinical trial NCT03976466: Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.
Official title: Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Keywords: Periprosthetic Joint Infection
Prophylaxis
Joint Replacement
Calcium Sulfate Beads
Lead sponsor: Hospital Regional Tlalnepantla
Sponsor class: OTHER_GOV
First posted: 2019-06-06
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Day 5, Weeks 4, 8, and 12
Secondary outcomes:
measure: Length of Stay as an Indicator of the Hospital Economic Burden
timeFrame: Surgical procedure day to hospital discharge.
Other outcomes:
Locations:
city: Tlalnepantla
country: Mexico
facility: HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM
Study officials:
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