Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT06733597
- Status
- Recruiting
Conditions
- Knee Arthropathy
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cement — PROCEDUREThe cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.
- Cementless — OTHERThe non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.
- Manual Surgery — PROCEDUREThe manual approach is the surgeon determining prosthetic placement using techniques developed during training.
- Robotic Surgery — PROCEDUREThe haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.
Study Details
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.
Key Dates
- Start date
- Mar 6, 2025
- Status verified
- Feb 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: Cemented and Manual
- Active Comparator: Cemented and Robotic
- Active Comparator: Cementless and Manual
- Active Comparator: Cementless and Robotic
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 ]
Central Contacts
- Osteoporosis Clinical Research Program608-265-6410
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UW School of Medicine and Public Health | Madison | Wisconsin | 53792 | - |
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