UW School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Location status: Recruiting
NCT Number: NCT06733597
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.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
Location status: Recruiting
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;
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.
The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.
The manual approach is the surgeon determining prosthetic placement using techniques developed during training.
The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.
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.
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.
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.
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.
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.
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.
Time frame: 2 weeks, 3 months, 12 months, 24 months
Participants will report pain from 0 (no pain) to 10 (worst possible pain)
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.
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.
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.
Time frame: 2 weeks, 3 months, 12 months, 24 months
Time frame: 2 weeks, 3 months, 12 months, 24 months
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty
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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