Clinical trial NCT04450199: Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Official title: Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin D Deficiency
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: The Podiatry Foundation
First posted: 2020-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The specific aim of this study is to assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing rates. With this information the investigators hope to ascertain if vitamin D supplementation in the perioperative period leads to superior fusion rates than does no supplementation.
Primary purpose: TREATMENT

Brief summary: To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).

Detailed description: This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient (\<30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.

The study will be conducted at 4 investigative sites within the Allegheny Health Network; West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics \& Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects are entering the follow-up phase of the study.

Eligibility criteria: Inclusion Criteria:

1. Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis surgery
2. Vitamin D serum level \<30 ng/mL including those concurrently taking vitamin D
3. Ambulatory
4. Women 18 years of age must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.

Exclusion Criteria:

1. Revision surgery
2. Tobacco use which has been shown to affect bone healing and increase risk of nonunion
3. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease (EXAMPLE below):

   AST/SGOT \> 2.0 times the upper limit of normal ALT/SGPT \> 2.0 times the upper limit of normal Total bilirubin \> 2.0 times the upper limit of normal Hemoglobin \< 9 gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 100,000/mm3 Creatinine \> 2.0 times the upper limit of normal
4. Preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
5. Preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
6. Open wounds to lower extremities which has been shown to increase risk of infection and nonunion
7. Any investigational drug use within 30 days prior to enrollment.
8. Participation in ongoing clinical research
9. Pregnant or lactating females.
10. Patients who are unable to swallow due to acuity of illness or physiologic reason
11. Patients who are unable to provide consent for the study including inability to read or speak English
12. Prisoners who are patients because of their vulnerable population and inability to follow-up
13. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Time to Union
timeFrame: 9 months
Secondary outcomes:
measure: Patient Reported Outcomes SF-36 Questionnaire
timeFrame: 9 months
measure: Patient Reported Outcomes VAS Survey Scores
timeFrame: 9 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The Foot & Ankle Institute/Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: The Foot & Ankle Institute, West Penn Hospital
name: Alan R Catanzariti, DPM, FACFAS
role: PRINCIPAL_INVESTIGATOR
References: