RECRUITING

Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications

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Conditions

Hip ArthropathyKnee ArthropathyVitamin D Deficiencyjoint replacementhip arthroplastyknee arthroplastyclinical outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Vitamin D status has been shown to have an effect on post-operative outcomes in total joint arthroplasty. The goal of this study is to determine if pre-operative supplementation and correction of Vitamin D deficiency can reduce postoperative complications.

Official Title

Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications

Quick Facts

Study Start:2019-09-01
Study Completion:2024-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04229368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients ≥18 years of age undergoing elective unilateral primary TJA for osteoarthritis
  2. * Patients with a pre-operative serum 25(OH)D levels ≥10 ng/mL
  3. * Patients who consent to the study
  1. * Adult patients ≥18 years of age undergoing elective primary TJA with a pre-operative serum 25(OH)D2,3 level \<10 ng/mL
  2. * Patients undergoing revision surgery
  3. * Patients lacking mental capacity to comply with study procedures
  4. * Patients with serum 25(OH)D levels between 10-29 ng/dL refusing to stop their current Vitamin D and multivitamins supplementations
  5. * Hypercalcemia (total calcium \>10.6 mg/dL or ionized serum calcium \>5.4mg/dL)
  6. * History of nephrolithiasis
  7. * Granulomatous disease
  8. * Dialysis and advanced kidney disease
  9. * Previous infection/septic arthritis
  10. * Inability to swallow Vitamin D3 pills
  11. * Allergy to Vitamin D3 (It is estimated that 1 in 300 individuals may have an allergy with skin manifestations 17)
  12. * Hypocalcemia (\<8.5 mg/dL)
  13. * Chronic kidney disease (eGFR \<60 mL/minute)
  14. * Known hyperparathyroidism
  15. * Known osteoporosis/insufficiency stress fractures (if normal stresses are applied to an abnormal bone)
  16. * Pregnancy

Contacts and Locations

Study Contact

Antonia F Chen, MD
CONTACT
617-525-5935
afchen@bwh.harvard.edu

Principal Investigator

Antonia F Chen, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Antonia F Chen, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-01
Study Completion Date2024-07-01

Study Record Updates

Study Start Date2019-09-01
Study Completion Date2024-07-01

Terms related to this study

Keywords Provided by Researchers

  • joint replacement
  • hip arthroplasty
  • knee arthroplasty
  • clinical outcomes
  • Vitamin D Deficiency

Additional Relevant MeSH Terms

  • Hip Arthropathy
  • Knee Arthropathy
  • Vitamin D Deficiency