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Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

Study Purpose

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 14 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 55 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06733597
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Brian Nickel, MD
Principal Investigator Affiliation UW School of Medicine and Public Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Arthropathy
Additional Details

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.#46; cementless prostheses. Specific Aim 1: In the entire study cohort, our primary endpoint is to estimate percent BMD change 12 months after TKA at the distal femur 25% region of interest (ROI). Specific Aim 1a: To compare percent BMD change 12 months after TKA at the distal femur 25% ROI in cemented vs.#46;uncemented implants. Specific Aim 1b: To compare percent BMD change 12 months after TKA at the distal femur 25% ROI in those receiving robotic vs.#46;manual implants. Specific Aim 2: In the entire study cohort, our secondary endpoints are to estimate percent BMD change 12 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 months after TKA at the distal femur 15% ROI and proximal tibial ROI in cemented vs.#46;uncemented implants. Specific Aim 2b: To compare percent BMD change 12 months after TKA at the distal femur 15% ROI and proximal tibial ROI in in those receiving robotic vs.#46;manual implants. Exploratory Aim 1: Compare patient reported pain and function at 2 weeks, 3 and 12 months: 1. in those receiving cemented and cementless implants. 2. in those receiving robotic vs.#46;manual implants. Exploratory Aim 2: Evaluate leg lean mass change as measured by DXA and BIS at 2 weeks, 3 and 12 months over time. 1. In the entire cohort. 2. in those receiving cemented and cementless implants. 3. in those receiving robotic vs.#46;manual implants.

Arms & Interventions

Arms

Active Comparator: Cemented and Manual

Active Comparator: Cemented and Robotic

Active Comparator: Cementless and Manual

Active Comparator: Cementless and Robotic

Interventions

Procedure: - Cement

The cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.

Other: - Cementless

The non-cement approach uses a different type of prosthetic that is placed tight against the bone and requires no other fixation material.

Procedure: - Manual Surgery

The manual approach is the surgeon determining prosthetic placement using techniques developed during training.

Procedure: - Robotic Surgery

The haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UW School of Medicine and Public Health, Madison, Wisconsin

Status

Recruiting

Address

UW School of Medicine and Public Health

Madison, Wisconsin, 53792

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