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NCT Number: NCT06733597

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

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.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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;

  • in those receiving cemented and cementless implants.
  • 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.

  • In the entire cohort
  • in those receiving cemented and cementless implants.
  • in those receiving robotic vs manual implants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cement

Procedure

The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.

Cementless

Other

The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.

Manual Surgery

Procedure

The manual approach is the surgeon determining prosthetic placement using techniques developed during training.

Robotic surgery

Procedure

The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.

Primary outcomes

  1. Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants

    Time frame: 12 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.

  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

    Time frame: 12 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.

  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

    Time frame: 12 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.

Secondary outcomes

  1. Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: All Participants

    Time frame: 12 months, 24 months

    Secondary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for all participants together.

  2. Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented

    Time frame: 12 months, 24 months

    Compare percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for cemented vs uncemented implants.

  3. Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual

    Time frame: 12 months, 24 months

    Compare percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for robotic vs manual implants.

Other outcomes

  1. Visual Analog Scale (VAS) for Patient Reported Pain

    Time frame: 2 weeks, 3 months, 12 months, 24 months

    Participants will report pain from 0 (no pain) to 10 (worst possible pain)

  2. Patient Reported Function measured by the Oxford Knee Score (OKS)

    Time frame: 2 weeks, 3 months, 12 months, 24 months

    OKS is a 12-item survey scored from 0-4 for a total possible range of scores from 0-48 where higher scores indicate better function.

  3. Patient Reported Function measured by the Koos Jr Knee Survey

    Time frame: 2 weeks, 3 months, 12 months, 24 months

    A 7-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better knee health.

  4. Patient Reported Function measured by the Forgotten Joint Survey

    Time frame: 2 weeks, 3 months, 12 months, 24 months

    A 12-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better outcomes.

  5. Change in Leg Lean Mass measured by Dual energy x-ray absorptiometry (DXA)

    Time frame: 2 weeks, 3 months, 12 months, 24 months

  6. Change in Leg Lean Mass measured by Bioelectrical impedance spectroscopy (BIS)

    Time frame: 2 weeks, 3 months, 12 months, 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Osteoporosis Clinical Research Program

CONTACT

[email protected]

608-265-6410

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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