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

Infection Clinical Trial

— Stimulan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976466
• Other study ID #: 01
• Status: Completed
• Phase: Phase 4
• Start date: May 22, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Hospital Regional Tlalnepantla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 15, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

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

Locations

Country	Name	City	State
Mexico	HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM	Tlalnepantla

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional Tlalnepantla

Country where clinical trial is conducted

Mexico, 

References & Publications (63)

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.