Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Hypovitaminosis D

In brief

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.

Key facts

Study ID

NCT01858051

Run by

Massachusetts General Hospital

People needed

0

Starts

2015-01-01

Expected to finish

2017-06-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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