Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo total knee arthroplasty with either cemented or cementless prostheses using manual or robotic surgery methods.
1 visit (in-person)
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
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
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