RecruitingNot ApplicableNCT06733597

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

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

Sponsor

University of Wisconsin, Madison

Enrollment

100 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 55 Years

Inclusion Criteria2

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 Criteria10

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)
(OH)D less than 20 ng/mL
Not suitable for study participation due to other reasons at the investigator's discretion

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Interventions

PROCEDURECement

The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.

OTHERCementless

The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.

PROCEDUREManual Surgery

The manual approach is the surgeon determining prosthetic placement using techniques developed during training.

PROCEDURERobotic Surgery

The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.

Locations(1)

UW School of Medicine and Public Health

Madison, Wisconsin, United States

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NCT06733597