Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty (NCT06733597) | Clinical Trial Compass
RecruitingNot Applicable
Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty
United States100 participantsStarted 2025-03-06
Plain-language summary
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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants
Timeframe: 12 months, 24 months
2
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented
Timeframe: 12 months, 24 months
3
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual