- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976466
Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors. (Stimulan)
Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Tlalnepantla, Mexico, 54090
- HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Other Names:
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Active Comparator: Control Group
Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement
|
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 5, Weeks 4, 8, and 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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Surgical procedure day to hospital discharge.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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- Sulo I. [Gentamycin impregnated plaster beads in the treatment of bone infection]. Rev Chir Orthop Reparatrice Appar Mot. 1993;79(4):299-305. French.
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- Aiken SS, Cooper JJ, Florance H, Robinson MT, Michell S. Local release of antibiotics for surgical site infection management using high-purity calcium sulfate: an in vitro elution study. Surg Infect (Larchmt). 2015 Feb;16(1):54-61. doi: 10.1089/sur.2013.162. Epub 2014 Aug 22.
- Howlin RP, Brayford MJ, Webb JS, Cooper JJ, Aiken SS, Stoodley P. Antibiotic-loaded synthetic calcium sulfate beads for prevention of bacterial colonization and biofilm formation in periprosthetic infections. Antimicrob Agents Chemother. 2015 Jan;59(1):111-20. doi: 10.1128/AAC.03676-14. Epub 2014 Oct 13.
- Howlin RP, Winnard C, Angus EM, Frapwell CJ, Webb JS, Cooper JJ, Aiken SS, Bishop JY, Stoodley P. Prevention of Propionibacterium acnes biofilm formation in prosthetic infections in vitro. J Shoulder Elbow Surg. 2017 Apr;26(4):553-563. doi: 10.1016/j.jse.2016.09.042. Epub 2016 Dec 15.
- Howlin RP, Winnard C, Frapwell CJ, Webb JS, Cooper JJ, Aiken SS, Stoodley P. Biofilm prevention of gram-negative bacterial pathogens involved in periprosthetic infection by antibiotic-loaded calcium sulfate beads in vitro. Biomed Mater. 2016 Dec 2;12(1):015002. doi: 10.1088/1748-605X/12/1/015002.
- Kallala R, Harris WE, Ibrahim M, Dipane M, McPherson E. Use of Stimulan absorbable calcium sulphate beads in revision lower limb arthroplasty: Safety profile and complication rates. Bone Joint Res. 2018 Nov 3;7(10):570-579. doi: 10.1302/2046-3758.710.BJR-2017-0319.R1. eCollection 2018 Oct.
- Lum ZC, Pereira GC. Local bio-absorbable antibiotic delivery in calcium sulfate beads in hip and knee arthroplasty. J Orthop. 2018 May 7;15(2):676-678. doi: 10.1016/j.jor.2018.05.001. eCollection 2018 Jun.
- Parvizi J, Pawasarat IM, Azzam KA, Joshi A, Hansen EN, Bozic KJ. Periprosthetic joint infection: the economic impact of methicillin-resistant infections. J Arthroplasty. 2010 Sep;25(6 Suppl):103-7. doi: 10.1016/j.arth.2010.04.011. Epub 2010 May 31.
- Parvizi J, Azzam K, Ghanem E, Austin MS, Rothman RH. Periprosthetic infection due to resistant staphylococci: serious problems on the horizon. Clin Orthop Relat Res. 2009 Jul;467(7):1732-9. doi: 10.1007/s11999-009-0857-z. Epub 2009 May 1.
- Almeida Herrero F, Lopez Lozano R, Silvestre Munoz A. [Descriptive analysis of C-Reactive values after uncomplicated total hip and knee arthroplasty]. Acta Ortop Mex. 2008 Mar-Apr;22(2):80-4. Spanish.
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- Greidanus NV, Masri BA, Garbuz DS, Wilson SD, McAlinden MG, Xu M, Duncan CP. Use of erythrocyte sedimentation rate and C-reactive protein level to diagnose infection before revision total knee arthroplasty. A prospective evaluation. J Bone Joint Surg Am. 2007 Jul;89(7):1409-16. doi: 10.2106/JBJS.D.02602.
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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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01 (Miami VAHS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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