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

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ClinicalTrials.gov Identifier: NCT03976466
Recruitment Status : Completed
First Posted : June 6, 2019
Results First Posted : August 18, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Julio Carlos Velez de Lachica, Hospital Regional Tlalnepantla

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.


Condition or disease Intervention/treatment Phase
Infection Device: Antibiotic local prophylaxis with medicated calcium sulfate beads Procedure: Classical parenteral antibiotic prophylaxis Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: No participant will know during the study in which group will be assigned.
Primary Purpose: Prevention
Official Title: Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections
Actual Study Start Date : May 22, 2019
Actual Primary Completion Date : April 22, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Calcium

Arm Intervention/treatment
Experimental: Calcium sulfate Group
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
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Other Name: Hip or Knee Joint Replacement

Active Comparator: Control Group
Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement
Procedure: Classical parenteral antibiotic prophylaxis
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Other Name: Hip pr Knee Joint Replacement




Primary Outcome Measures :
  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. [ Time Frame: Day 5, Weeks 4, 8, and 12 ]
    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.


Secondary Outcome Measures :
  1. Length of Stay as an Indicator of the Hospital Economic Burden [ Time Frame: Surgical procedure day to hospital discharge. ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976466


Locations
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Mexico
HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM
Tlalnepantla, Mexico, 54090
Sponsors and Collaborators
Hospital Regional Tlalnepantla
  Study Documents (Full-Text)

Documents provided by Julio Carlos Velez de Lachica, Hospital Regional Tlalnepantla:
Publications:

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Responsible Party: Julio Carlos Velez de Lachica, Md. High Specialty Associate Professor of the Joint Surgery Course., Hospital Regional Tlalnepantla
ClinicalTrials.gov Identifier: NCT03976466    
Other Study ID Numbers: 01
First Posted: June 6, 2019    Key Record Dates
Results First Posted: August 18, 2020
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Julio Carlos Velez de Lachica, Hospital Regional Tlalnepantla:
Periprosthetic Joint Infection
Prophylaxis
Joint Replacement
Calcium Sulfate Beads
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anti-Infective Agents
Antitubercular Agents