Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Launched by UNIVERSITY OF WISCONSIN, MADISON · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how the density of bone in the thigh (femur) changes before and after knee replacement surgery, specifically comparing two types of surgeries: cemented and cementless. The goal is to understand how these surgeries, which can be done manually or with robotic assistance, affect bone health in patients with knee issues. The study will involve 100 participants who are at least 55 years old and have not had previous knee replacement surgery on the same leg.

To be part of this study, participants should have normal bone density or slight bone loss, but not severe osteoporosis. They should not have a history of certain fractures or be currently taking medications for osteoporosis. Those who qualify can expect to be involved in the study for up to 14 months, during which their bone density will be monitored. This research will help improve our understanding of how different knee surgeries impact bone health, which is important for recovery and overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients age greater than or equal to 55 years undergoing TKA with no prior total joint arthroplasty on the surgical side
• • 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.
• Exclusion Criteria:
• * Known clinical osteoporosis defined as any one of the following:
• • Hip or spine T-score less than or equal to -2.5
• • History of low trauma fracture after age 50
• • 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
• • Prior or current use of osteoporosis medications
• • Current use of systemic glucocorticoids or bone-active medications
• • Rheumatoid arthritis
• • Laboratory abnormalities that in the opinion of study investigators may impact bone mineral density; including calcium, creatinine, albumin and parathyroid hormone (PTH)
• • 25(OH)D less than 20 ng/mL
• • Not suitable for study participation due to other reasons at the investigator's discretion