Recruiting

Total Knee Arthroplasty

Sponsor:

University of Wisconsin, Madison

Code:

NCT06733597

Conditions

Knee Arthropathy

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Cement

Cementless

Manual Surgery

Robotic Surgery

Study Details

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.

Conditions

Knee Arthropathy

Study ID

NCT06733597

Start date

Mar 6, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Cemented and Manual

active comparator: Cemented and Robotic

active comparator: Cementless and Manual

active comparator: Cementless and Robotic

Interventions

Cement

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

Cementless

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

Manual Surgery

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

Robotic Surgery

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Osteoporosis Clinical Research Program

608-265-6410uwocrp@aging.wisc.edu

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • bone mineral density

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-02-19.