Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients



Status:Not yet recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2015
End Date:June 2017
Contact:Caitlin McCarthy, BA
Email:cmccarthy@psrtners.org

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Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery

In the United States, ~1 million elective hip or knee replacement surgeries are performed
annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this
represents ~25,000 patients at risk of potentially avoidable morbidity following lower
extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they
are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also
been identified as an independent risk factor for infections of implanted hardware.

In general, the majority of PJIs become apparent within 3 months of hardware implantation,
but deep infections may not be evident for up to one year after surgery. Hardware infections
result in delayed healing, repeated surgical interventions, and long-term antibiotic
therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional
expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate
compared to uninfected lower extremity joint replacements.

Recent work from our group suggests that vitamin D insufficiency may be a risk factor for
perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in
elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in
the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery.
To date, perioperative vitamin D optimization strategies have not been reported. Therefore,
our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative
and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in
patients scheduled for elective hip or knee joint replacement surgery.


Inclusion Criteria:

- Male or female

- Age ≥18 years

- English or Spanish speaking

- Scheduled for preoperative clinic assessment

- Scheduled to have elective hip or knee joint replacement surgery

- Not taking more than 1000 IU of either cholecalciferol or ergocalciferol daily

Exclusion Criteria:

- Unable to provide consent

- Inability to comply with study protocol

- History of anemia (hematocrit <25%)

- History of renal stones or hypercalcemia

- Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis,
myeloma)

- Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis
medication)

- Already enrolled or planning to enroll in a research study that would conflict with
full participation in the current study or confound the observation or interpretation
of the study findings
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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