Knee ArthropathyNCT06733597
Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty
A study testing Cement, Cementless and Manual Surgery in people with Knee Arthropathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Cement, Cementless and Manual Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Fracture Risk Assessment Tool (FRAX) not meeting Bone Health and Osteoporosis Foundation (BHOF) treatment recommendations, i.e., 10-year major osteoporotic fracture risk greater then or equal to 20 percent or hip fracture risk greater than or equal to 3 percent.
Who cannot join
- Known clinical osteoporosis defined as any one of the following:
- Hip or spine T-score less than or equal to -2.5
- History of low trauma fracture after age 50
- FRAX fracture risk calculation greater than or equal to 20 percent for major osteoporotic fracture or greater than or equal to 3 percent for hip fracture
- Prior or current use of osteoporosis medications
- Current use of systemic glucocorticoids or bone-active medications
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty
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.
Read the detailed description
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;
- in those receiving cemented and cementless implants.
- in those receiving robotic vs manual implants.
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.
- In the entire cohort
- in those receiving cemented and cementless implants.
- in those receiving robotic vs manual implants.
- Conditions
- Knee Arthropathy
- Being tested
- Cement, Cementless, Manual Surgery, Robotic Surgery
- Keywords
- bone mineral density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CementProcedure or surgery
The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.
CementlessOther
The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.
Manual SurgeryProcedure or surgery
The manual approach is the surgeon determining prosthetic placement using techniques developed during training.
Robotic SurgeryProcedure or surgery
The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.
| Study group | Role | What they receive |
|---|---|---|
| Cemented and Manual | Active comparator | Not described Receives: Procedure: Cement; Procedure: Manual Surgery |
| Cemented and Robotic | Active comparator | Not described Receives: Procedure: Cement; Procedure: Robotic Surgery |
| Cementless and Manual | Active comparator | Not described Receives: Other: Cementless; Procedure: Manual Surgery |
| Cementless and Robotic | Active comparator | Not described Receives: Other: Cementless; Procedure: Robotic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months, 24 months
Secondary outcomes (3)
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.
Measured: 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: 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.
Measured: 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.
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start6 Mar 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Nickel, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733597
- Sponsor's protocol ID
- 2024-0197
- Other IDs
- Protocol Version 1/9/2026, A536110
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Bone Mineral Density (BMD) Change Following Cemented or Cementless Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06733597
- Acronym / sponsor ID
- 2024-0197
- Conditions
- Knee Arthropathy
- Keywords
- bone mineral density
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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;
- in those receiving cemented and cementless implants.
- in those receiving robotic vs manual implants.
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.
- In the entire cohort
- in those receiving cemented and cementless implants.
- in those receiving robotic vs manual implants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cemented and Manual | Active comparator | Procedure: Cement, Procedure: Manual Surgery |
| Cemented and Robotic | Active comparator | Procedure: Cement, Procedure: Robotic Surgery |
| Cementless and Manual | Active comparator | Other: Cementless, Procedure: Manual Surgery |
| Cementless and Robotic | Active comparator | Other: Cementless, Procedure: Robotic Surgery |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 Fracture Risk Assessment Tool (FRAX) not meeting Bone Health and Osteoporosis Foundation (BHOF) treatment recommendations, i.e., 10-year major osteoporotic fracture risk greater then or equal to 20 percent or hip fracture risk greater than or equal to 3 percent.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CementThe cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic. | Procedure or surgery | Cemented and Manual, Cemented and Robotic |
| CementlessThe non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material. | Other | Cementless and Manual, Cementless and Robotic |
| Manual SurgeryThe manual approach is the surgeon determining prosthetic placement using techniques developed during training. | Procedure or surgery | Cemented and Manual, Cementless and Manual |
| Robotic SurgeryThe haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic. | Procedure or surgery | Cemented and Robotic, Cementless and Robotic |
Primary outcome
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
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.
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Cemented vs Uncemented
Time frame: 12 months, 24 months
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.
Percent Change in Bone Mineral Density within 25 percent of the region of interest at 12 and 24 months post TKA: Robotic vs Manual
Time frame: 12 months, 24 months
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.
3 secondary outcomes
Percent Change in Bone Mineral Density within 15 percent of the region of interest at 12 and 24 months post TKA: All Participants
Time frame: 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: Cemented vs Uncemented
Time frame: 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
Time frame: 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Nickel, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cement, Cementless and Manual Surgery in people with Knee Arthropathy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osteoporosis Clinical Research Program (608-265-6410, uwocrp@aging.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.