Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
ID06733597

Femoral Bone Mineral Density Change After Cemented or Cementless Total Knee Arthroplasty Using Manual or Robotic Surgery

Led by University of Wisconsin, Madison · Updated on 2026-02-19

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how femur bone mineral density (BMD) changes before and after total knee arthroplasty (TKA) surgery in patients aged 55 and older. The study compares BMD changes in patients receiving either cemented or cementless knee implants and evaluates differences between surgeries done manually or with robotic assistance. The goal is to better understand bone loss patterns and how surgical methods may affect outcomes over time. Participants will undergo TKA surgery using one of four approaches: cemented with manual surgery, cemented with robotic surgery, cementless with manual surgery, or cementless with robotic surgery. The cemented method involves inserting cement to fix the prosthetic, while the cementless method uses prosthetics that fit tightly without cement. Robotic surgery uses computer assistance for implant placement, whereas manual surgery relies on traditional surgical techniques. The study will follow patients for up to 26 months after surgery. During the study, participants will have bone density measured at specific regions of the distal femur and proximal tibia at 12 and 24 months post-surgery. Researchers will also assess patient-reported pain, function, and changes in leg lean mass at multiple time points including 2 weeks, 3 months, 12 months, and 24 months. These evaluations will help determine how the different surgical methods impact bone health and recovery. Safety and eligibility monitoring will be conducted throughout the study period.

CONDITIONS

Brief Title

Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 55 years or older undergoing total knee arthroplasty without prior joint replacement on the surgical side
  • Normal bone mineral density or osteopenia without meeting Bone Health and Osteoporosis Foundation treatment recommendations based on fracture risk assessment
Not Eligible

You will not qualify if you...

  • Known clinical osteoporosis defined by low hip or spine T-score, history of low trauma fracture after age 50, or high fracture risk scores
  • Prior or current use of osteoporosis medications
  • Current use of systemic glucocorticoids or other bone-active medications
  • Diagnosis of rheumatoid arthritis
  • Laboratory abnormalities affecting bone mineral density such as abnormal calcium, creatinine, albumin, parathyroid hormone levels
  • Vitamin D (25[OH]D) levels less than 20 ng/mL
  • Other reasons deemed unsuitable for participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo total knee arthroplasty with either cemented or cementless prostheses using manual or robotic surgery methods.

1 visit (in-person)

Post-operative Follow-up

Duration - 24 months

Participants are followed to assess bone mineral density changes, pain, function, and leg lean mass over time after surgery.

Visits at 2 weeks, 3 months, 12 months, and 24 months (in-person)

Trial Site Locations

Total: 1 location

1

UW School of Medicine and Public Health

Madison, Wisconsin, United States, 53792

Actively Recruiting

Loading map...

Research Team

O

Osteoporosis Clinical Research Program

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

Similar Trials

Evaluation of Clinical Outcomes of the Triathlon Hinge Knee ...

Knee Arthropathy

Actively Recruiting

2 locations

Improving Total Knee Arthroplasty Dissatisfaction at 1-year ...

Knee Osteoarthritis

Actively Recruiting

1 location

A Prospective Clinical Investigation of Robotic-assisted TKA...

Knee Arthropathy

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here