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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04772196
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Medical University of South Carolina
Information provided by (Responsible Party):
Prisma Health-Midlands

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ankle Arthrodesis MTP Arthrodesis Drug: Vitamin D3 Early Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
No Intervention: Control Group
Patients enrolled in the control group will receive standard of care.
Experimental: Vitamin D Supplementation Group
Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks.
Drug: Vitamin D3
50,000 IU Vitamin D3 weekly for 8 weeks

Primary Outcome Measures :
  1. Post-surgical complication rate following Vitamin D3 supplementation [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04772196

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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Prisma Health
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Prisma Health-Midlands
Medical University of South Carolina
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Principal Investigator: Rebecca Senehi, MD Prisma Health-Midlands

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Responsible Party: Prisma Health-Midlands Identifier: NCT04772196    
Other Study ID Numbers: Pro00095065
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents