Ankle ArthrodesisEarly Phase 1NCT04772196
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
A Early Phase 1 study testing Vitamin D3 in people with Ankle Arthrodesis and MTP Arthrodesis, run by Prisma Health-Midlands at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ankle Arthrodesis, MTP Arthrodesis
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2020to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age
- Subject is undergoing ankle arthrodesis or MTP arthrodesis
- Subject speaks and understands English
Who cannot join
- Subject is < 18 years of age
- Subject has an active joint infection
- Subject is unable to provide consent
- Subject is a prisoner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Prisma Health
Columbia, South Carolina, 29203
About this study
Official title: Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis
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.
Read the 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
- Being tested
- Vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
50,000 IU Vitamin D3 weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients enrolled in the control group will receive standard of care. |
| Vitamin D Supplementation Group | Experimental | Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical complication rate following Vitamin D3 supplementation
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start21 Dec 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ankle ArthrodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772196
- Sponsor's protocol ID
- Pro00095065
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23737771Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
PubMed 20926724Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.
PubMed 20511058Lavernia CJ, Villa JM, Iacobelli DA, Rossi MD. Vitamin D insufficiency in patients with THA: prevalence and effects on outcome. Clin Orthop Relat Res. 2014 Feb;472(2):681-6. doi: 10.1007/s11999-013-3172-7.
PubMed 23868422Somerson JS, Bartush KC, Shroff JB, Bhandari M, Zelle BA. Loss to follow-up in orthopaedic clinical trials: a systematic review. Int Orthop. 2016 Nov;40(11):2213-2219. doi: 10.1007/s00264-016-3212-5. Epub 2016 May 3.
PubMed 27142421Zelle 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.
PubMed 23449099Kristman 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.
PubMed 15469032Nwankwo 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.
PubMed 31466668
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis
- ClinicalTrials.gov ID
- NCT04772196
- Acronym / sponsor ID
- Pro00095065
- Conditions
- Ankle Arthrodesis, MTP Arthrodesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients enrolled in the control group will receive standard of care. |
| Vitamin D Supplementation Group | Experimental | Drug: Vitamin D3Patients enrolled in the Vitamin D Supplementation Group will receive 50,000 IU Vitamin D3 weekly for 8 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years of age
- Subject is undergoing ankle arthrodesis or MTP arthrodesis
- Subject speaks and understands English
Key exclusion criteria (4 listed)
- Subject is < 18 years of age
- Subject has an active joint infection
- Subject is unable to provide consent
- Subject is a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D350,000 IU Vitamin D3 weekly for 8 weeks | Drug | Vitamin D Supplementation Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 23737771Bentli 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.
- Background: PubMed 20926724Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.
- Background: PubMed 20511058Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.
- Background: PubMed 23868422Lavernia CJ, Villa JM, Iacobelli DA, Rossi MD. Vitamin D insufficiency in patients with THA: prevalence and effects on outcome. Clin Orthop Relat Res. 2014 Feb;472(2):681-6. doi: 10.1007/s11999-013-3172-7.
- Background: PubMed 27142421Somerson JS, Bartush KC, Shroff JB, Bhandari M, Zelle BA. Loss to follow-up in orthopaedic clinical trials: a systematic review. Int Orthop. 2016 Nov;40(11):2213-2219. doi: 10.1007/s00264-016-3212-5. Epub 2016 May 3.
- Background: PubMed 23449099Zelle 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.
- Background: PubMed 15469032Kristman 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.
- Background: PubMed 31466668Nwankwo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D3 in people with Ankle Arthrodesis and MTP Arthrodesis, run by Prisma Health-Midlands at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical complication rate following Vitamin D3 supplementation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772196, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.