NCT06733597

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Knee Arthropathy

Interventions

Type	Name	Description
PROCEDURE	Cement	The cemented approach includes inserting cement into the femur and tibia prior to setting 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.
PROCEDURE	Manual Surgery	The manual approach is the surgeon determining prosthetic placement using techniques developed during training.
PROCEDURE	Robotic Surgery	The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.

Timeline

• Start date: 2025-03-06
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-12-13
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States