Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty
ConditionKnee Arthropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cement
Procedure/SurgeryThe cemented approach includes inserting cement into the femur and tibia prior to setting the prosthetic.
Cementless
Other interventionThe 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/SurgeryThe manual approach is the surgeon determining prosthetic placement using techniques developed during training.
Robotic Surgery
Procedure/SurgeryThe haptic robotic assisted approach uses a computer and robot to determine specific placement of the prosthetic.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Cemented and ManualActive comparator 2 interventions
Group B: Cemented and RoboticActive comparator 2 interventions
Group C: Cementless and ManualActive comparator 2 interventions
Group D: Cementless and RoboticActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months, 24 months2
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.
Time frame
12 months, 24 months3
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.
Time frame
12 months, 24 monthsSecondary outcomes
1
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.
Time frame
12 months, 24 months2
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.
Time frame
12 months, 24 months3
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.
Time frame
12 months, 24 monthsOther outcomes
1
Visual Analog Scale (VAS) for Patient Reported Pain
Participants will report pain from 0 (no pain) to 10 (worst possible pain)
Time frame
2 weeks, 3 months, 12 months, 24 months2
Patient Reported Function measured by the Oxford Knee Score (OKS)
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.
Time frame
2 weeks, 3 months, 12 months, 24 months3
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.
Time frame
2 weeks, 3 months, 12 months, 24 months4
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.
Time frame
2 weeks, 3 months, 12 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov