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Prophylaxis of Periprosthetic...

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

Last Updated: 2020-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2020-07-15

Brief Summary

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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.

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Detailed Description

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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

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

No participant will know during the study in which group will be assigned.

Study Groups

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Calcium sulfate Group

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

Group Type EXPERIMENTAL

Antibiotic local prophylaxis with medicated calcium sulfate beads

Intervention Type DEVICE

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

Control Group

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

Group Type ACTIVE_COMPARATOR

Classical parenteral antibiotic prophylaxis

Intervention Type PROCEDURE

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

Interventions

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Antibiotic local prophylaxis with medicated calcium sulfate beads

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

Intervention Type DEVICE

Classical parenteral antibiotic prophylaxis

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

Intervention Type PROCEDURE

Other Intervention Names

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Hip or Knee Joint Replacement Hip pr Knee Joint Replacement

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Julio Carlos Velez de Lachica

Md. High Specialty Associate Professor of the Joint Surgery Course.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM

Tlalnepantla, , Mexico

Site Status

Countries

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Mexico

References

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de Lachica JCV, Reyes SSS, Urena JAP, Fragoso MAR. Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial. J ISAKOS. 2022 Dec;7(6):201-205. doi: 10.1016/j.jisako.2022.08.002. Epub 2022 Aug 13.

Reference Type DERIVED

PMID: 35973626 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Infection Prophylaxis in Total Joint Replacement

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

Antibiotic Loaded Cement After TKA

Detailed Description

Conditions

Study Design

Study Groups

Calcium sulfate Group

Antibiotic local prophylaxis with medicated calcium sulfate beads

Control Group

Classical parenteral antibiotic prophylaxis

Interventions

Antibiotic local prophylaxis with medicated calcium sulfate beads

Classical parenteral antibiotic prophylaxis

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hospital Regional Tlalnepantla

Responsible Party

Julio Carlos Velez de Lachica

Locations

HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM

Countries

References

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