Phase 4 N=87 Randomized Single-blind Prevention

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

Infection

Bottom Line

View on ClinicalTrials.gov: NCT03976466 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: 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. — 27; 4; 13; 39 Participants — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Antibiotic local prophylaxis with medicated calcium sulfate beads (Device); Classical parenteral antibiotic prophylaxis (Procedure)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Hospital Regional Tlalnepantla
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
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.	27; 4; 13; 39	<0.05 sig
SECONDARY Length of Stay as an Indicator of the Hospital Economic Burden	15.25; 4.6	<0.01 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03976466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.