Examining bone density changes after knee replacement surgery
Official title: Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty
Run by University of Wisconsin, Madison · NCT06733597 · Data updated 2026-11-12
This study is testing how knee replacement surgery affects bone density in the thigh bone for people using different types of implants and surgical methods over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | March 6, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT06733597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 55 and older undergoing total knee arthroplasty with normal bone density or osteopenia.
✕Probably not a fit
Patients with known clinical osteoporosis or those currently using osteoporosis medications are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates changes in femur bone mineral density (BMD) before and after total knee arthroplasty (TKA) using either cemented or cementless implants, performed through manual or robotic methods. A total of 100 participants will be enrolled and monitored for up to 14 months. The primary aim is to estimate the percent change in BMD at the distal femur 12 months post-surgery, comparing outcomes between the two surgical methods. Secondary aims include assessing BMD changes at additional regions of interest and evaluating patient-reported pain and function over time.
Why it matters
Potential benefit: If successful, this study could help optimize surgical techniques for knee replacement, potentially reducing bone loss and improving recovery outcomes for patients.
How similar studies have gone: Previous studies have indicated significant bone loss following TKA, but this specific comparison of surgical methods is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UW School of Medicine and Public Health
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Brian Nickel, MD — UW School of Medicine and Public Health
- Study coordinator: Osteoporosis Clinical Research Program
- Email: uwocrp@aging.wisc.edu
- Phone: 608-265-6410
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.