Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Last updated: February 17, 2026
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cement

Cementless

Manual Surgery

Clinical Study ID

NCT06733597
2024-0197
A536110
Protocol Version 1/9/2026
Protocol Version 10/31/24
  • Ages > 55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients age greater than or equal to 55 years undergoing TKA with no prior totaljoint arthroplasty on the surgical side

  • Normal BMD or osteopenia with Fracture Risk Assessment Tool (FRAX) not meeting BoneHealth and Osteoporosis Foundation (BHOF) treatment recommendations, i.e., 10-yearmajor osteoporotic fracture risk greater then or equal to 20 percent or hip fracturerisk greater than or equal to 3 percent.

Exclusion

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 majorosteoporotic 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 bonemineral 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'sdiscretion

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Cement
Phase:
Study Start date:
March 06, 2025
Estimated Completion Date:
June 30, 2028

Study Description

It has previously been reported that total knee arthroplasty (TKA) causes major femur bone loss (~18% within 1 year). Prior studies did not examine different surgical methods, such as the use of cement or robotics, in TKA. The investigators hypothesize that previously reported differences in distal femur BMD change following TKA exist between patients receiving cemented vs. cementless prostheses.

Specific Aim 1: In the entire study cohort, our primary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur 25% region of interest (ROI).

Specific Aim 1a: To compare percent BMD change 12 and 24 months after TKA at the distal femur 25% ROI in cemented vs uncemented implants.

Specific Aim 1b: To compare percent BMD change 12 and 24 months after TKA at the distal femur 25% ROI in those receiving robotic vs manual implants.

Specific Aim 2: In the entire study cohort, our secondary endpoints are to estimate percent BMD change 12 and 24 months after TKA at a.) the distal femur 15% ROI and b.) a proximal tibial ROI Specific Aim 2a: To compare percent BMD change 12 and 24 months after TKA at the distal femur 15% ROI and proximal tibial ROI in cemented vs uncemented implants.

Specific Aim 2b: To compare percent BMD change 12 and 24 months after TKA at the distal femur 15% ROI and proximal tibial ROI in in those receiving robotic vs manual implants.

Exploratory Aim 1: Compare patient reported pain and function at 2 weeks, 3 months, 12 months, and 24 months;

  1. in those receiving cemented and cementless implants.

  2. in those receiving robotic vs manual implants.

Exploratory Aim 2: Evaluate leg lean mass change as measured by DXA and BIS at 2 weeks, 3 months, 12 months, and 24 months over time.

  1. In the entire cohort

  2. in those receiving cemented and cementless implants.

  3. in those receiving robotic vs manual implants.

Connect with a study center

  • UW School of Medicine and Public Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • UW School of Medicine and Public Health

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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