Trial Outcomes & Findings for Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors. (NCT NCT03976466)
NCT ID: NCT03976466
Last Updated: 2020-08-20
Results Overview
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.
COMPLETED
PHASE4
87 participants
Day 5, Weeks 4, 8, and 12
2020-08-20
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Calcium Sulfate Group
n=43 Participants
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
|
Control Group
n=40 Participants
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
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 8.14 • n=43 Participants
|
77.3 years
STANDARD_DEVIATION 8.9 • n=40 Participants
|
76.6 years
STANDARD_DEVIATION 8.5 • n=83 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=43 Participants
|
22 Participants
n=40 Participants
|
44 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=43 Participants
|
18 Participants
n=40 Participants
|
39 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
43 participants
n=43 Participants
|
40 participants
n=40 Participants
|
83 participants
n=83 Participants
|
|
non-modifiable risk factors
Body Mass Index
|
10 Participants
n=43 Participants
|
6 Participants
n=40 Participants
|
16 Participants
n=83 Participants
|
|
non-modifiable risk factors
Wound Drain, dehiscence or surgical active infecti
|
2 Participants
n=43 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=83 Participants
|
|
non-modifiable risk factors
History of nosocomial infection
|
3 Participants
n=43 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=83 Participants
|
|
non-modifiable risk factors
Prolonged surgical time
|
3 Participants
n=43 Participants
|
4 Participants
n=40 Participants
|
7 Participants
n=83 Participants
|
|
non-modifiable risk factors
Decompensated Type 2 Diabetes Mellitus
|
8 Participants
n=43 Participants
|
7 Participants
n=40 Participants
|
15 Participants
n=83 Participants
|
|
non-modifiable risk factors
Serum Albumin
|
1 Participants
n=43 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=83 Participants
|
|
non-modifiable risk factors
Rheumatoid Arthritis
|
2 Participants
n=43 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=83 Participants
|
|
non-modifiable risk factors
Blood transfusion Transoperative Bleeding
|
7 Participants
n=43 Participants
|
5 Participants
n=40 Participants
|
12 Participants
n=83 Participants
|
|
non-modifiable risk factors
History of prosthetic surgery
|
3 Participants
n=43 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=83 Participants
|
|
non-modifiable risk factors
Immunosuppression
|
0 Participants
n=43 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=83 Participants
|
|
non-modifiable risk factors
Malignancy
|
3 Participants
n=43 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=83 Participants
|
|
non-modifiable risk factors
Corticosteroid Therapy
|
1 Participants
n=43 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=83 Participants
|
|
Location of Joint Prosthesis
KNEE
|
17 Participants
n=43 Participants
|
21 Participants
n=40 Participants
|
38 Participants
n=83 Participants
|
|
Location of Joint Prosthesis
HIP
|
26 Participants
n=43 Participants
|
19 Participants
n=40 Participants
|
45 Participants
n=83 Participants
|
|
Periprosthetic Joint Infection
With periprosthetic infection
|
4 Participants
n=43 Participants
|
27 Participants
n=40 Participants
|
31 Participants
n=83 Participants
|
|
Periprosthetic Joint Infection
Without periprosthetic infection
|
39 Participants
n=43 Participants
|
13 Participants
n=40 Participants
|
52 Participants
n=83 Participants
|
PRIMARY outcome
Timeframe: Day 5, Weeks 4, 8, and 12Population: Patients who agreed to join the study and who met the selection criteria. After 3 moths presents or not periprosthetic joint infection.
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.
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Calcium Sulfate Group
n=43 Participants
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
|
|---|---|---|
|
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
|
4 Participants
|
|
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
|
39 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Calcium Sulfate Group
n=43 Participants
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
|
|---|---|---|
|
Length of Stay as an Indicator of the Hospital Economic Burden
|
15.25 Days
Standard Deviation 10.06
|
4.6 Days
Standard Deviation 4.62
|
Adverse Events
Calcium Sulfate Study Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place