Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery

Study Overview
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Brief Summary
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Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively. This study will assess the effect of vitamin D supplementation on patient outcomes following ankle arthrodesis or first metatarsophalangeal joint arthrodesis.

Detailed Description
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The current status of knowledge includes preliminary research correlating hypovitaminosis, or low vitamin D status, to worse outcomes. In orthopaedic patients, vitamin D deficiency is prevalent among those scheduled to undergo surgery. Vitamin D is important for calcium homeostasis and bone health, as well as for activation and differentiation of macrophages, dendritic cells, and lymphocytes. A recent retrospective review of outcomes in revision total joint arthroplasty patients showed that patients with low vitamin D had higher rates of postoperative complications and periprosthetic infections. Additionally, another retrospective study correlated low vitamin D levels with lower patient reported outcomes (PROs) after total hip arthroplasty. Current retrospective studies suggest that having low vitamin D levels may lead to impaired fracture healing, increased wound complication rates, and a higher risk of infections. Given this background information, this study will investigate a series of patients undergoing ankle arthrodesis and first metatarsophalangeal joint (MTP) arthrodesis. Our study will serve to enhance the current knowledge as a level 1 randomized control study on the effect of Vitamin D supplementation on the complication rate following these two arthrodesis procedures. Our endpoints for complications will be defined as infection, wound healing complications, need for readmission, need for re-operation and nonunion as evidenced clinically and radiographically.

Official Title
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Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis

Conditions
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Ankle Arthrodesis, MTP Arthrodesis

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age Subject is undergoing ankle arthrodesis or MTP arthrodesis Subject speaks and understands English Exclusion Criteria: Subject is < 18 years of age Subject has an active joint infection Subject is unable to provide consent Subject is a prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to receive either standard of care or supplemental Vitamin D3 following total ankle arthroplasty, ankle arthrodesis, or first metatarsophalangeal joint arthrodesis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients enrolled in the control group will receive standard of care. | |
| Experimental: Vitamin D Supplementation Group<br>Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks. | Drug: Vitamin D3<br>* 50,000 IU Vitamin D3 weekly for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-surgical complication rate following Vitamin D3 supplementation | Patients will be followed for 6 months post-operatively to determine overall complication rate in patients receiving Vitamin D3 supplementation vs. standard of care. Complications will include infection, wound healing complications, readmission, re-operation, and clinical or radiographic nonunion. | 6 months |