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Clinical Trials/NCT06733597
NCT06733597RecruitingNot Applicable

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

University of Wisconsin, Madison1 site in 1 country100 target enrollmentStarted: March 6, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants

Study Overview

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Cemented and Manual

Active Comparator

Intervention: Cement (Procedure)

Cemented and Manual

Active Comparator

Intervention: Manual Surgery (Procedure)

Cemented and Robotic

Active Comparator

Intervention: Cement (Procedure)

Cemented and Robotic

Active Comparator

Intervention: Robotic Surgery (Procedure)

Cementless and Manual

Active Comparator

Intervention: Cementless (Other)

Cementless and Manual

Active Comparator

Intervention: Manual Surgery (Procedure)

Cementless and Robotic

Active Comparator

Intervention: Cementless (Other)

Cementless and Robotic

Active Comparator

Intervention: Robotic Surgery (Procedure)

Outcomes

Primary Outcomes

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.

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.

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

  • Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: All Participants(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(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(12 months, 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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