RECRUITING

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

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Conditions

Knee Arthropathybone mineral density

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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

The purpose of this study is to examine femur bone mineral density (BMD) change before and after surgery in patients receiving cemented or cementless total knee arthroplasty (TKA). performed with manual or robotic methods. 100 participants will be enrolled and can expect to be on study for up to 26 months.

Official Title

Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty

Quick Facts

Study Start:2025-03-06
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06733597

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:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients age greater than or equal to 55 years undergoing TKA with no prior total joint arthroplasty on the surgical side
  2. * Normal BMD or osteopenia with Fracture Risk Assessment Tool (FRAX) not meeting Bone Health and Osteoporosis Foundation (BHOF) treatment recommendations, i.e., 10-year major osteoporotic fracture risk greater then or equal to 20 percent or hip fracture risk greater than or equal to 3 percent.
  1. * Known clinical osteoporosis defined as any one of the following:
  2. * Hip or spine T-score less than or equal to -2.5
  3. * History of low trauma fracture after age 50
  4. * FRAX fracture risk calculation greater than or equal to 20 percent for major osteoporotic fracture or greater than or equal to 3 percent for hip fracture
  5. * Prior or current use of osteoporosis medications
  6. * Current use of systemic glucocorticoids or bone-active medications
  7. * Rheumatoid arthritis
  8. * Laboratory abnormalities that in the opinion of study investigators may impact bone mineral density; including calcium, creatinine, albumin and parathyroid hormone (PTH)
  9. * 25(OH)D less than 20 ng/mL
  10. * Not suitable for study participation due to other reasons at the investigator's discretion

Contacts and Locations

Study Contact

Osteoporosis Clinical Research Program
CONTACT
608-265-6410
uwocrp@aging.wisc.edu

Principal Investigator

Brian Nickel, MD
PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health

Study Locations (Sites)

UW School of Medicine and Public Health
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Brian Nickel, MD, PRINCIPAL_INVESTIGATOR, UW School of Medicine and Public Health

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 Date2025-03-06
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • bone mineral density

Additional Relevant MeSH Terms

  • Knee Arthropathy