NCT03272178

Impact of Component Design and Fixation in Total Knee Arthroplasty

Impact of Component Design and Fixation in Bone Remodeling After Total Knee Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine implant design and determine if method of fixation cemented versus cementless results in different bone loss patterns. The investigators also want to determine if clinical outcomes correlate with bone density changes.

Detailed description

Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and are suitable candidates for primary total knee arthroplasty(TKA) type assigned either cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for eligibility and invited to participate. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, Dual Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.

Conditions

• Arthroplasties, Knee Replacement

Interventions

Type	Name	Description
DEVICE	Depuy total knee implant	patients from Dr Nunley's clinic will get a Depuy implant
DEVICE	Triathlon total knee implant	patients from Dr Barrack's clinic will get a Triathlon implant

Timeline

• Start date: 2017-11-20
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2017-09-05
• Last updated: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study