Infection
Conditions
Keywords
Periprosthetic Joint Infection, Prophylaxis, Joint Replacement, Calcium Sulfate Beads
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.
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.
Interventions
DEVICEAntibiotic local prophylaxis with medicated calcium sulfate beads
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
PROCEDUREClassical parenteral antibiotic prophylaxis
Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Sponsors
Hospital Regional Tlalnepantla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
No participant will know during the study in which group will be assigned.
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay as an Indicator of the Hospital Economic Burden | 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. |
Countries
Mexico
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 40 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Calcium Sulfate Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 75.9 years STANDARD_DEVIATION 8.14 | 77.3 years STANDARD_DEVIATION 8.9 | 76.6 years STANDARD_DEVIATION 8.5 |
| Location of Joint Prosthesis HIP | 26 Participants | 19 Participants | 45 Participants |
| Location of Joint Prosthesis KNEE | 17 Participants | 21 Participants | 38 Participants |
| non-modifiable risk factors Blood transfusion Transoperative Bleeding | 7 Participants | 5 Participants | 12 Participants |
| non-modifiable risk factors Body Mass Index | 10 Participants | 6 Participants | 16 Participants |
| non-modifiable risk factors Corticosteroid Therapy | 1 Participants | 0 Participants | 1 Participants |
| non-modifiable risk factors Decompensated Type 2 Diabetes Mellitus | 8 Participants | 7 Participants | 15 Participants |
| non-modifiable risk factors History of nosocomial infection | 3 Participants | 3 Participants | 6 Participants |
| non-modifiable risk factors History of prosthetic surgery | 3 Participants | 1 Participants | 4 Participants |
| non-modifiable risk factors Immunosuppression | 0 Participants | 1 Participants | 1 Participants |
| non-modifiable risk factors Malignancy | 3 Participants | 0 Participants | 3 Participants |
| non-modifiable risk factors Prolonged surgical time | 3 Participants | 4 Participants | 7 Participants |
| non-modifiable risk factors Rheumatoid Arthritis | 2 Participants | 5 Participants | 7 Participants |
| non-modifiable risk factors Serum Albumin | 1 Participants | 4 Participants | 5 Participants |
| non-modifiable risk factors Wound Drain, dehiscence or surgical active infecti | 2 Participants | 4 Participants | 6 Participants |
| Periprosthetic Joint Infection Without periprosthetic infection | 39 Participants | 13 Participants | 52 Participants |
| Periprosthetic Joint Infection With periprosthetic infection | 4 Participants | 27 Participants | 31 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Mexico | 43 participants | 40 participants | 83 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 21 Participants | 18 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 0 / 44 | 0 / 43 |
| serious Total, serious adverse events | 0 / 44 | 0 / 43 |
Outcome results
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.
Time frame: Day 5, Weeks 4, 8, and 12
Population: Patients who agreed to join the study and who met the selection criteria. After 3 moths presents or not periprosthetic joint infection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | 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. | With Periprosthetic Joint infection | 27 Participants |
| Control Group | 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. | Without periprosthetic infection | 13 Participants |
| Calcium Sulfate Group | 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. | With Periprosthetic Joint infection | 4 Participants |
| Calcium Sulfate Group | 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. | Without periprosthetic infection | 39 Participants |
Comparison: H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test.p-value: <0.0595% CI: [0.015, 0.168]Chi-squared, Corrected
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.
Time frame: Surgical procedure day to hospital discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Length of Stay as an Indicator of the Hospital Economic Burden | 15.25 Days | Standard Deviation 10.06 |
| Calcium Sulfate Group | Length of Stay as an Indicator of the Hospital Economic Burden | 4.6 Days | Standard Deviation 4.62 |
Comparison: Lenght of stay was the variable that compares both groups and was a continous variable (t-test).p-value: <0.01t-test, 2 sided