Osteoarthritis
Conditions
Brief summary
This is a prospective, randomized, controlled, open label, parallel four-arm design, multi-center study to compare different intraoperative interventions in the prevention of acute PJI development.
Detailed description
The study seeks to define the potential benefits that an additional prophylactic protocol involving the use of povidone iodine and vancomycin powder on the incidence of PJI in high risk TJA patients. The potential benefits of these interventions are significant both from the perspective of reducing morbidity and mortality for the patient, and from a cost-effectiveness and value-based perspective. To this end, our study seeks to assess the direct and indirect costs associated with the treatment and control groups. We anticipate that the administration of a VPIP protocol will both reduce the incidence of PJI in high risk groups relative to the control arm and will demonstrate added value from a cost-effectiveness perspective. This study looks to examine off-label use of Vancomycin Powder and Povidone Iodine 10% solution. Both products are lawfully marketed in the United States. This study is not intended to be reported to the FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling or advertising of either drug. This study does not involve a route of administration, dose, patient population, or other factor that significantly increased the risk (or decreases the acceptability of the risk) associated with the use of the drug product. The routes and dosages being tested in this protocol are part of standard clinical care in most total joint arthroplasty surgeries.
Interventions
DRUGPovidone iodine
To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
OTHERConventional
No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient has no open wounds on operative leg * Patient is scheduled to undergo elective primary and revision total joint arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis * Patient does not have active infection on the operative leg, the operative joint * Patient are identified as high risk for the development of PJI which is determined by the presence of one or more of the following characteristics: BMI \>35, active smoker, ASA ≥ 3, immunosuppressed (i.e. being treated with chemotherapy, diagnosis of HIV, diagnosis of HCV, being treated with chronic steroids, patients with inflammatory arthropathies), diagnosis with diabetes mellitus, established colonization with S. aureus, or any patient undergoing revision TJA * Patient understand the risks and benefits associated with TJA and willing to cooperate and follow study protocol and visit schedule
Exclusion criteria
* Patient is pregnant * Patient is unable to provide written consent * Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility * Patient does not have the mental capacity to participate and comply with the study protocol * Patient has active infections in the operative leg/joint * Patient has severe dementia * Suspicion of illicit drug abuse by patient * ASA score of 5 \& 6 * History of prior native septic joint arthritis * No planned procedure within 90 days of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Periprosthetic Infection (PJI) After Elective Total Joint Arthroplasty. | 90 Days | The definition of periprosthetic infection exists when the following criteria are met: * NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28 * Major Criteria: \[1\] sinus tract \[2\] + Cx from 2 separate aspirations * Minor Criteria: \[1\] ESR \>30 mm/hr (1 point), \[2\] D-dimer \>860 ng/mL or CRP \>1 mg/dL \[2\] increased synovial WBC (\>3000 cells/microliter) \[4\] alpha-defensin (signal-to-cutoff ratio\>1) \[5\] leukocyte esterase (++) \[6\] increased synovial PMNs of \>80% \[7\] synovial CRP \>6.9 mg/L |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRan Schwarzkopf, MD
NYU Langone
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 488 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 43 Participants |
| Race (NIH/OMB) Black or African American | 94 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 57 Participants |
| Race (NIH/OMB) White | 1172 Participants |
| Region of Enrollment United States | 455 participants |
| Sex: Female, Male Female | 1067 Participants |
| Sex: Female, Male Male | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 511 | 1 / 524 | 1 / 489 | 1 / 531 |
| other Total, other adverse events | 24 / 511 | 25 / 524 | 20 / 489 | 22 / 531 |
| serious Total, serious adverse events | 12 / 511 | 10 / 524 | 15 / 489 | 12 / 531 |
Outcome results
None listed