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

Phase 4

Completed

Interventions: Device: Antibiotic local prophylaxis with medicated calcium sulfate beads
Procedure: Classical parenteral antibiotic prophylaxis

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Calcium sulfate Group	Antibiotic local prophylaxis with medicated calcium sulfate beads	Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement
Control Group	Classical parenteral antibiotic prophylaxis	Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement

Primary Outcome Measures

Name	Time	Method
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.	Day 5, Weeks 4, 8, and 12	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.

Secondary Outcome Measures

Name	Time	Method
Length of Stay as an Indicator of the Hospital Economic Burden	Surgical procedure day to hospital discharge.	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.