NCT04772196

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

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Prisma Health-Midlands · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ankle Arthrodesis
• MTP Arthrodesis

Interventions

Type	Name	Description
DRUG	Vitamin D3	50,000 IU Vitamin D3 weekly for 8 weeks

Timeline

• Start date: 2020-12-21
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-02-26
• Last updated: 2025-12-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study