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Procedure

Cemented vs Cementless Knee Replacement for Knee Osteoarthritis

N/A
Recruiting
Led By Brian Nickel, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 FRAX not meeting BHOF treatment recommendations, i.e., 10-year major osteoporotic fracture risk greater than or equal to 20 percent or hip fracture risk greater than or equal to 3 percent.
Must not have
Current use of systemic glucocorticoids or bone-active medications
Rheumatoid arthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 3 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how bone density in the thigh bone changes before and after knee replacement surgery using different methods. 100 people will take part and the study will last for up to 14 months

Who is the study for?
This trial is for individuals with knee osteoarthritis or rotator cuff syndrome who require total knee arthroplasty (TKA). Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedures involved.
What is being tested?
The study is examining bone density changes in the femur after TKA using either cemented or cementless techniques. It also compares manual versus robotic surgery methods. Participants will be monitored over a period of up to 14 months.
What are the potential side effects?
While specific side effects are not listed, typical risks may include pain at the surgery site, infection, blood clots, stiffness in the knee joint, and possible issues related to bone density changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 or older and have not had joint replacement surgery on the side being considered for a new knee.
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My bone density is normal or slightly low without high fracture risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking steroids or medications for my bones.
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I have rheumatoid arthritis.
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I have been diagnosed with osteoporosis.
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I have taken medication for osteoporosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 3 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 3 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: All Participants
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: Cemented vs Uncemented
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 months post TKA: Robotic vs Manual
Secondary study objectives
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: All Participants
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: Cemented vs Uncemented
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 months post TKA: Robotic vs Manual
Other study objectives
Patient Reported Function measured by the Forgotten Joint Survey
Patient Reported Function measured by the Koos Jr Knee Survey
Patient Reported Function measured by the Oxford Knee Score (OKS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Cemented and ManualActive Control2 Interventions
Group II: Cementless and ManualActive Control2 Interventions
Group III: Cementless and RoboticActive Control2 Interventions
Group IV: Cemented and RoboticActive Control2 Interventions

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Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,879 Total Patients Enrolled
Brian Nickel, MDPrincipal InvestigatorUW School of Medicine and Public Health
~67 spots leftby Dec 2026
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