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

Hospital Regional Tlalnepantla

Status and phase

Completed

Phase 4

Conditions

Infection

Treatments

Procedure: Classical parenteral antibiotic prophylaxis

Device: Antibiotic local prophylaxis with medicated calcium sulfate beads

Study type

Interventional

Funder types

Other

Identifiers

NCT03976466

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.