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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 : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
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)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : April 22, 2020
Estimated Study Completion Date : July 22, 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. To compare local against conventional intravenous prophylaxis in peri-prosthetic hip or knee infection of patients with non- modifiable risk factors. [ Time Frame: 3 months ]
    • To compare the prevalence of peri-prosthetic hip or knee infection with antibiotic prophylaxis between control (intravenous) versus study group (local with calcium sulfate beads). Intravenous prophylaxis group (control) will use 1 gr of ceftriaxone 30 minutes before surgery and study group will use prophylaxis by calcium sulfate beads loaded with 3 gr of vancomycin in the transoperative procedure, as interface between the acetabulum and the metal cup and between the femoral canal and the porous stem in the hip; for the knee, calcium sulfate beads will be applied in the femoral and tibial canal and in the soft ridged tissue. Using the data collection sheet, investigators will fill-in variables to determine acute peri-prosthetic infection using CRP, ESR and Leucocytes in synovial fluid in the next 5 days, 4, 6, 8 and 12 weeks. Once all the results have been obtained, a statistic analysis will be carried out using T student and measure of central tendency statistics.


Secondary Outcome Measures :
  1. Establish differences in the cost benefit of prophylaxis with or without calcium sulfate beads. [ Time Frame: 3 months ]
    The control and study groups will be analyzed with ANOVA test for differences in economics criteria: costs for time in the operating room, hospital stay, outpatient visits and additional procedures. Statistical analysis of both groups will be carried out. Any statistically meaningful differences will be used to calculate potential health economic benefits of the experimental group, based upon information on standard costs.



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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


Contacts
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Contact: Julio C Velez de Lachica, Md 52 1 26269200 ext 2100 activeknee@gmail.com
Contact: Miguel A Ruiz Fragoso, Md 52126269200 ext 2101 mike1889@gmail.com

Locations
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Mexico
HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM Recruiting
Tlalnepantla, Mexico, 54090
Contact: Manuel Felipe A Rodriguez, Director    52126269200    manuel_aportela@hotmail.com   
Principal Investigator: Julio C Velez de Lachica, Md         
Sub-Investigator: Miguel A Ruiz Fragoso, Md         
Sub-Investigator: Juan A Pages Ureña, Md         
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
Last Update Posted: June 6, 2019
Last Verified: June 2019

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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 beds
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Calcium, Dietary
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcium
Anti-Infective Agents
Antitubercular Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents