Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Femoral Bone Mineral Density (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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Procedure: Cement; Procedure: Manual Surgery; Procedure: Robotic Surgery; Other: Cementless

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osteoporosis Clinical Research Program; Phone Number: 608-265-6410; Email: uwocrp@aging.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • UW School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cemented and Manual	Procedure: Cement; The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.; Procedure: Manual Surgery; The manual approach is the surgeon determining prosthetic placement using techniques developed during training.
Active Comparator: Cemented and Robotic	Procedure: Cement; The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.; Procedure: Robotic Surgery; The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.
Active Comparator: Cementless and Manual	Procedure: Manual Surgery; The manual approach is the surgeon determining prosthetic placement using techniques developed during training.; Other: Cementless; The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.
Active Comparator: Cementless and Robotic	Procedure: Robotic Surgery; The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.; Other: Cementless; The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants	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.	12 months, 24 months
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented	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.	12 months, 24 months
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual	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.	12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: All Participants	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.	12 months, 24 months
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented	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.	12 months, 24 months
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual	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.	12 months, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for Patient Reported Pain	Participants will report pain from 0 (no pain) to 10 (worst possible pain)	2 weeks, 3 months, 12 months, 24 months
Patient Reported Function measured by the Oxford Knee Score (OKS)	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.	2 weeks, 3 months, 12 months, 24 months
Patient Reported Function measured by the Koos Jr Knee Survey	A 7-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better knee health.	2 weeks, 3 months, 12 months, 24 months
Patient Reported Function measured by the Forgotten Joint Survey	A 12-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better outcomes.	2 weeks, 3 months, 12 months, 24 months
Change in Leg Lean Mass measured by Dual energy x-ray absorptiometry (DXA)		2 weeks, 3 months, 12 months, 24 months
Change in Leg Lean Mass measured by Bioelectrical impedance spectroscopy (BIS)		2 weeks, 3 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Brian Nickel, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: bone mineral density
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Surgical Procedures, Operative; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Automation; Technology; Dental Materials; Surgery, Computer-Assisted; Robotics; Robotic Surgical Procedures; Dental Cements
• Other Study ID Numbers: 2024-0197; A536110 (Other Identifier: UW Madison); Protocol Version 1/9/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No