NCT03976466

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Hospital Regional Tlalnepantla · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
DEVICE	Antibiotic local prophylaxis with medicated calcium sulfate beads	Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
PROCEDURE	Classical parenteral antibiotic prophylaxis	Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

Timeline

• Start date: 2019-05-22
• Primary completion: 2020-04-22
• Completion: 2020-07-15
• First posted: 2019-06-06
• Last updated: 2020-08-20
• Results posted: 2020-08-18

Locations

1 site across 1 country: Mexico