Joint Diseases Clinical Trial
Official title:
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Verified date | March 2023 |
Source | The Methodist Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
Status | Completed |
Enrollment | 23 |
Est. completion date | September 1, 2022 |
Est. primary completion date | May 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Patient is undergoing a primary total hip arthroplasty - Patient gives informed consent to participate in the study. - Age Range >18 Exclusion Criteria: - Previous surgery on the hip (including hip scopes) - BMI above 35 - Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc) - Inability to locate the greater trochanter or administer the IO infusion - Refusal to participate - Diabetes - Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications). |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Methodist Hospital Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systemic Vancomycin level | vancomycin blood level at time of initiation of closure. | 1 year | |
Secondary | Tissue vancomycin level | at start and end of case. | 1 year | |
Secondary | Femur vancomycin level | at start and end of case. | 1 year | |
Secondary | Acetabulum vancomycin level | at start and end of case. | 1 year | |
Secondary | 30-Day Complications | Complications 30 days post surgery i.e. infection. | From the administration of antibiotics perioperatively to 30 days post op. | |
Secondary | 90-Day Complications | Complications 90 days post surgery i.e. infection | From the administration of antibiotics perioperatively to 90 days post op. |
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