Prosthetic Joint Infection
Conditions
Keywords
Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration
Brief summary
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
Interventions
COMBINATION_PRODUCTvancomycin hydrochloride and tobramycin sulfate
vancomycin hydrochloride and tobramycin sulfate via local irrigation
Sponsors
Osteal Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years or greater * Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection * Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al. * Medical clearance for surgery * Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol
Exclusion criteria
* Late acute hematogenous infection per Tsukayama et al. * Patients for whom a two-stage exchange arthroplasty is not indicated * Sepsis * Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed) * Patients with PJI of more than one joint * Patients on chronic antibiotic therapy (≥ 6 months duration) * Patients who require therapeutic anticoagulation * Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated * Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl) * Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels \> 8.0% * Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day). * Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.) * Anticipated or potential patient relocation that may interfere with follow-up examinations * Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy) * Patients who are pregnant or planning to become pregnant * Patients in whom negative pressure wound therapy is contraindicated * Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion * Breastfeeding at screening visit * Patients who are prisoners * Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluations: Number and Frequency of Adverse Events Among Participants | 12 months | The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Joint irrigation with vancomycin and tobramycin
vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Affected Joint Hip | 1 Participants |
| Affected Joint Knee | 14 Participants |
| Age, Continuous | 69.27 Years STANDARD_DEVIATION 7.329 |
| Age, Customized <60 years | 2 Participants |
| Age, Customized >= 60 years | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 14 / 15 |
| serious Total, serious adverse events | 7 / 15 |
Outcome results
Primary
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Any Adverse Event | 14 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | AE Relationship to NPWT Device UNRELATED | 14 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | AE Relationship to Study Medication UNRELATED | 14 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | AE Relationship to Study Treatment Procedure UNRELATED | 14 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Severity - Mild | 14 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Severity - Moderate | 7 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Severity - Severe | 6 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Serious Adverse Event | 7 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | SAE Relationship to NPWT Device UNRELATED | 7 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | SAE Relationship to Study Medication UNRELATED | 7 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | SAE Relationship to Study Treatment Procedure UNRELATED | 7 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Suspected Adverse Reaction | 0 Participants |
| Experimental | Safety Evaluations: Number and Frequency of Adverse Events Among Participants | Adverse Reactions | 0 Participants |