Clinical trial NCT04772196: Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Official title: Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Ankle Arthrodesis
MTP Arthrodesis
Lead sponsor: Prisma Health-Midlands
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2021-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-surgical complication rate following Vitamin D3 supplementation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
References:
citation: Bentli R, Taskapan H, Toktas H, Ulutas O, Ozkahraman A, Comert M. Significant independent predictors of vitamin d deficiency in inpatients and outpatients of a nephrology unit. Int J Endocrinol. 2013;2013:237869. doi: 10.1155/2013/237869. Epub 2013 May 12.
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citation: Zelle BA, Bhandari M, Sanchez AI, Probst C, Pape HC. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013 Mar;27(3):177-81. doi: 10.1097/BOT.0b013e31825cf367.
citation: Kristman V, Manno M, Cote P. Loss to follow-up in cohort studies: how much is too much? Eur J Epidemiol. 2004;19(8):751-60. doi: 10.1023/b:ejep.0000036568.02655.f8.
citation: Nwankwo EC Jr, Labaran LA, Athas V, Olson S, Adams SB. Pathogenesis of Posttraumatic Osteoarthritis of the Ankle. Orthop Clin North Am. 2019 Oct;50(4):529-537. doi: 10.1016/j.ocl.2019.05.008.