Clinical trial NCT06733597: Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty
Official title: Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Keywords: bone mineral density
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 14 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 months after TKA at the distal femur 25% region of interest (ROI).

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

Specific Aim 1b: To compare percent BMD change 12 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 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 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 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 and 12 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 and 12 months over time.

1. In the entire cohort
2. in those receiving cemented and cementless implants.
3. in those receiving robotic vs manual implants.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: All Participants
timeFrame: 12 months
measure: Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: Cemented vs Uncemented
timeFrame: 12 months
measure: Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: Robotic vs Manual
timeFrame: 12 months
Secondary outcomes:
measure: Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: All Participants
timeFrame: 12 months
measure: Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: Cemented vs Uncemented
timeFrame: 12 months
measure: Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: Robotic vs Manual
timeFrame: 12 months
Other outcomes:
measure: Visual Analog Scale (VAS) for Patient Reported Pain
timeFrame: 2 weeks, 3 months, 12 months
measure: Patient Reported Function measured by the Oxford Knee Score (OKS)
timeFrame: 2 weeks, 3 months, 12 months
measure: Patient Reported Function measured by the Koos Jr Knee Survey
timeFrame: 2 weeks, 3 months, 12 months
measure: Patient Reported Function measured by the Forgotten Joint Survey
timeFrame: 2 weeks, 3 months, 12 months
measure: Change in Leg Lean Mass measured by Dual energy x-ray absorptiometry (DXA)
timeFrame: 2 weeks, 3 months, 12 months
measure: Change in Leg Lean Mass measured by Bioelectrical impedance spectroscopy (BIS)
timeFrame: 2 weeks, 3 months, 12 months
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Brian Nickel, MD
role: PRINCIPAL_INVESTIGATOR
References: