Femoral BMD Change Following Cemented or Cementless Total Knee Arthroplasty

NCT06733597 | Recruiting

• 3 other identifiers: 2024-0197Protocol Version 1/9/2026A536110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthropathy

Keywords

bone mineral density

Outcome Measures

Primary Outcomes (3)

• 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

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

  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

  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

  12 months, 24 months

Other Outcomes (6)

• Visual Analog Scale (VAS) for Patient Reported Pain

  2 weeks, 3 months, 12 months, 24 months

• Patient Reported Function measured by the Oxford Knee Score (OKS)

  2 weeks, 3 months, 12 months, 24 months

• Patient Reported Function measured by the Koos Jr Knee Survey

  2 weeks, 3 months, 12 months, 24 months

Study Arms (4)

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

Interventions

Cement PROCEDURE

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

Cemented and Manual; Cemented and Robotic

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.

Cementless and Manual; Cementless and Robotic

Manual Surgery PROCEDURE

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

Cemented and Manual; Cementless and Manual

Robotic Surgery PROCEDURE

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

Cemented and Robotic; Cementless and Robotic

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• (OH)D less than 20 ng/mL
• Not suitable for study participation due to other reasons at the investigator's discretion

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Interventions

Dental Cements; Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology

Study Officials

• Brian Nickel, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osteoporosis Clinical Research Program

CONTACT

608-265-6410; uwocrp@aging.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)