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

NCT03976466 | Completed Phase 4 Results DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Periprosthetic Joint Infection; Prophylaxis; Joint Replacement; Calcium Sulfate Beads

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of Stay as an Indicator of the Hospital Economic Burden

  Surgical procedure day to hospital discharge.

Study Arms (2)

Calcium sulfate Group

EXPERIMENTAL

Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement

Device: Antibiotic local prophylaxis with medicated calcium sulfate beads

Control Group

ACTIVE COMPARATOR

Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement

Procedure: Classical parenteral antibiotic prophylaxis

Interventions

Antibiotic local prophylaxis with medicated calcium sulfate beads DEVICE

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

Also known as: Hip or Knee Joint Replacement

Calcium sulfate Group

Classical parenteral antibiotic prophylaxis PROCEDURE

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

Also known as: Hip pr Knee Joint Replacement

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Regional Tlalnepantla: lead

Study Sites (1)

HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM

Tlalnepantla, 54090, Mexico

Location

Related Publications (64)

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  PMID: 35973626 DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Julio Carlos Vélez de Lachica, Head of the orthopedics department at Regional Hospital Tlalnepantla
• Organization: ISSEMyM Instituto de Seguridad Social del Estado de Mexico y Municipios

activeknee@gmail.com

5526269200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No participant will know during the study in which group will be assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md. High Specialty Associate Professor of the Joint Surgery Course.

Model Details: Randomised controlled trial. Study participants are randomly assigned to one of two groups: the experimental group receiving the Calcium sulfate beds with antibiotics and a comparison group (control) which receives a conventional prophylactic therapy.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 6, 2019
• Study Start: May 22, 2019
• Primary Completion: April 22, 2020
• Study Completion: July 15, 2020
• Last Updated: August 20, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

ME (1)