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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 1/9/2026 | Other Identifier | UW Madison | |
| A536110 | Other Identifier | UW Madison |
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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.
It has previously been reported that total knee arthroplasty (TKA) causes major femur bone loss (~18% within 1 year). Prior studies did not examine different surgical methods, such as the use of cement or robotics, in TKA. The investigators hypothesize that previously reported differences in distal femur BMD change following TKA exist between patients receiving cemented vs. cementless prostheses.
Specific Aim 1: In the entire study cohort, our primary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur 25% region of interest (ROI).
Specific Aim 1a: To compare percent BMD change 12 and 24 months after TKA at the distal femur 25% ROI in cemented vs uncemented implants.
Specific Aim 1b: To compare percent BMD change 12 and 24 months after TKA at the distal femur 25% ROI in those receiving robotic vs manual implants.
Specific Aim 2: In the entire study cohort, our secondary endpoints are to estimate percent BMD change 12 and 24 months after TKA at a.) the distal femur 15% ROI and b.) a proximal tibial ROI Specific Aim 2a: To compare percent BMD change 12 and 24 months after TKA at the distal femur 15% ROI and proximal tibial ROI in cemented vs uncemented implants.
Specific Aim 2b: To compare percent BMD change 12 and 24 months after TKA at the distal femur 15% ROI and proximal tibial ROI in in those receiving robotic vs manual implants.
Exploratory Aim 1: Compare patient reported pain and function at 2 weeks, 3 months, 12 months, and 24 months;
Exploratory Aim 2: Evaluate leg lean mass change as measured by DXA and BIS at 2 weeks, 3 months, 12 months, and 24 months over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented and Manual | Active Comparator |
| |
| Cemented and Robotic | Active Comparator |
| |
| Cementless and Manual | Active Comparator |
| |
| Cementless and Robotic | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cement | Procedure | The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: All Participants | Primary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest, reported for all participants together. | 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 | Compare percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest between all cemented and uncemented implants. | 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 | Compare percent BMD change 12 and 24 months after TKA at the distal femur, 25 percent region of interest between all robotic vs manual implants. | 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: All Participants | Secondary endpoint is to estimate percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for all participants together. | 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Patient Reported Pain | Participants will report pain from 0 (no pain) to 10 (worst possible pain) | 2 weeks, 3 months, 12 months, 24 months |
| Patient Reported Function measured by the Oxford Knee Score (OKS) |
Inclusion Criteria:
Exclusion Criteria:
Known clinical osteoporosis defined as any one of the following:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osteoporosis Clinical Research Program | Contact | 608-265-6410 | uwocrp@aging.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian Nickel, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D003738 | Dental Cements |
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Cementless | Other | 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 | Procedure | The manual approach is the surgeon determining prosthetic placement using techniques developed during training. |
|
| Robotic Surgery | Procedure | The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic. |
|
| Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented | Compare percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for cemented vs uncemented implants. | 12 months, 24 months |
| Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual | Compare percent BMD change 12 and 24 months after TKA at the distal femur and the proximal tibia, 15 percent region of interest, reported for robotic vs manual implants. | 12 months, 24 months |
OKS is a 12-item survey scored from 0-4 for a total possible range of scores from 0-48 where higher scores indicate better function.
| 2 weeks, 3 months, 12 months, 24 months |
| Patient Reported Function measured by the Koos Jr Knee Survey | A 7-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better knee health. | 2 weeks, 3 months, 12 months, 24 months |
| Patient Reported Function measured by the Forgotten Joint Survey | A 12-item survey scored from 0-4 with cumulative scores converted to 0-100, where higher scores indicate better outcomes. | 2 weeks, 3 months, 12 months, 24 months |
| Change in Leg Lean Mass measured by Dual energy x-ray absorptiometry (DXA) | 2 weeks, 3 months, 12 months, 24 months |
| Change in Leg Lean Mass measured by Bioelectrical impedance spectroscopy (BIS) | 2 weeks, 3 months, 12 months, 24 months |
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |