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

Prisma Health-Midlands

Status and phase: Active, not recruiting; Early Phase 1

Conditions: MTP Arthrodesis; Ankle Arthrodesis

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT04772196

Pro00095065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients enrolled in the control group will receive standard of care.

Vitamin D Supplementation Group

Experimental group

Description:

Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks.

Treatment:

Drug: Vitamin D3