Total Knee Replacement and Bone Density Study

This study is looking at how total knee replacement (TKA) affects the bone mineral density (BMD) in your thigh bone (femur). Researchers want to see if there are differences in BMD changes based on whether your knee implant is put in with cement (cemented) or without cement (cementless). They also want to compare BMD changes when the surgery is done manually by a surgeon versus with the help of a robot (robotic surgery). You might be able to join if you are 55 years or older, are having your first total knee replacement on that side, and have normal or slightly low bone density. The study aims to understand how these different surgical methods impact your bone density after surgery. The study plans to enroll 100 participants, and the status of recruitment is unclear.

Study design
This is an interventional study planning to enroll 100 participants. It compares different surgical methods for total knee replacement.
What's involved
You would be on study for up to 26 months, with bone mineral density measurements taken at 12 and 24 months after your total knee replacement.
Compensation
Not stated in the trial record.
Follow-up
Participants will have their bone mineral density measured at 12 and 24 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06733597

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Recruiting
NAAges 55+InterventionalBasic science
University of Wisconsin, Madison
~100 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:CementCementlessManual SurgeryRobotic Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants
Measured over 12 months, 24 months
+2 more outcomes measured
Knee Arthropathy
1 sites across 1 states
Wisconsin1
  • Brian Nickel, MD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health
Osteoporosis Clinical Research Program
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants12 months, 24 months

    Primary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest, reported for all participants together.

  • Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented12 months, 24 months

    Compare percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest between all cemented and uncemented implants.

  • Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual12 months, 24 months

    Compare percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest between all robotic vs manual implants.