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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium sulfate Group | Experimental | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement |
|
| Control Group | Active Comparator | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic local prophylaxis with medicated calcium sulfate beads | Device | Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay as an Indicator of the Hospital Economic Burden | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM | Tlalnepantla | 54090 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19493644 | Background | Ong KL, Kurtz SM, Lau E, Bozic KJ, Berry DJ, Parvizi J. Prosthetic joint infection risk after total hip arthroplasty in the Medicare population. J Arthroplasty. 2009 Sep;24(6 Suppl):105-9. doi: 10.1016/j.arth.2009.04.027. Epub 2009 Jun 2. | |
| 18421542 | Background | Pulido L, Ghanem E, Joshi A, Purtill JJ, Parvizi J. Periprosthetic joint infection: the incidence, timing, and predisposing factors. Clin Orthop Relat Res. 2008 Jul;466(7):1710-5. doi: 10.1007/s11999-008-0209-4. Epub 2008 Apr 18. |
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Inclusion critera for patients to complete enrolled protocol were: patients over 60 years old, no history of cephalosporine allergy, to have any of the non-modifiable risk factors, patients who accept blood transfusion. Patientes who are institutional entitled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Sulfate Study Group | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 5, 2020 |
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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.
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No participant will know during the study in which group will be assigned.
|
| Classical parenteral antibiotic prophylaxis | Procedure | Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection |
|
|
| Surgical procedure day to hospital discharge. |
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| 35973626 | Derived | 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. |
| FG001 | Control Group | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Sulfate Group | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection |
| BG001 | Control Group | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| non-modifiable risk factors | Count of Participants | Participants |
| ||||||||||||||||
| Location of Joint Prosthesis | Count of Participants | Participants |
| ||||||||||||||||
| Periprosthetic Joint Infection | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who agreed to join the study and who met the selection criteria. After 3 moths presents or not periprosthetic joint infection. | Posted | Count of Participants | Participants | Day 5, Weeks 4, 8, and 12 |
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| Secondary | Length of Stay as an Indicator of the Hospital Economic Burden | 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. | Posted | Mean | Standard Deviation | Days | Surgical procedure day to hospital discharge. |
|
3 months after surgical procedure.
Adverse mortality events from all causes, serious or other (non-serious) adverse events were monitored but none observed in the 3 months after the surgical procedure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Sulfate Study Group | Group of members that will be submitted to prophylaxis with medicated calcium sulfate beads for hip or knee joint replacement Antibiotic local prophylaxis with medicated calcium sulfate beads: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 3g of vancomycin mixed with Stimulan Kit (Biocomposites Ltd, United Kingdom) which includes 10 cc (20 g) of calcium sulfate hemihydrate powder | 0 | 44 | 0 | 44 | 0 | 44 |
| EG001 | Control Group | Group of members that will be submitted to classic prophylaxis for hip or knee joint replacement Classical parenteral antibiotic prophylaxis: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection. 750 mgs of Intra Venous Ceftriaxone 20 minutes before joint replacement surgery and every 8 hours for 24 hours | 0 | 43 | 0 | 43 | 0 | 43 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julio Carlos Vélez de Lachica, Head of the orthopedics department at Regional Hospital Tlalnepantla | ISSEMyM Instituto de Seguridad Social del Estado de Mexico y Municipios | 5526269200 | 2100 | activeknee@gmail.com |
| Aug 6, 2020 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Wound Drain, dehiscence or surgical active infecti |
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| History of nosocomial infection |
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| Prolonged surgical time |
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| Decompensated Type 2 Diabetes Mellitus |
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| Serum Albumin |
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| Rheumatoid Arthritis |
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| Blood transfusion Transoperative Bleeding |
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| History of prosthetic surgery |
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| Immunosuppression |
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| Malignancy |
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| Corticosteroid Therapy |
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| Superiority |
| Units | Counts |
|---|---|
| Participants |
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