Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
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|ClinicalTrials.gov Identifier: NCT04772196|
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ankle Arthrodesis MTP Arthrodesis||Drug: Vitamin D3||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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)|
|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|
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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04772196
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Columbia, South Carolina, United States, 29203|
|Principal Investigator:||Rebecca Senehi, MD||Prisma Health-Midlands|