Impact of Component Design and Fixation in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasties, Knee Replacement
• Intervention / Treatment: Device: Triathlon total knee implant; Device: Depuy total knee implant

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant

Description

Inclusion Criteria:

• Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
• 18-75 years of age
• Willing to sign informed consent
• Willing to return for all follow-up visits

Exclusion Criteria:

• Patients with inflammatory arthritis
• BMI > 40
• Patient with an active infection or suspected infection in the joint
• Patient who have undergone osteotomy
• Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with weak bones and/or currently on medications to increase bone density/who have poor bone quality
• Patients who have had previous patella fracture or surgery
• Patients who have had previous knee or hip replacement surgery on the ipsilateral side
• Patients who require patellar resurfacing
• Patient with major medical/muscular/orthopedic deformities
• Unable to undergo DEXA scanning.
• Female patients of childbearing potential and an interest in getting pregnant in the future *NOTE: Patients receiving simultaneous bilateral total knee arthroplasties are eligible. Both knees are eligible for enrollment as long as all other inclusion/exclusion criteria are met for each knee. If only one knee is eligible it will be included. Patients receiving staged bilaterals are also eligible, provided that each knee meets the inclusion exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Triathlon knee total knee arthroplasty; 50 Patients who are assigned to Triathlon knee, half cemented/half cementless	Device: Triathlon total knee implant; patients from Dr Barrack's clinic will get a Triathlon implant
Depuy knee total knee arthroplasty; 50 Patients who are assigned to Depuy knee, half cemented/half cementless	Device: Depuy total knee implant; patients from Dr Nunley's clinic will get a Depuy implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone density	Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee society score	Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years
Forgotten joint score	Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years
Oxford knee score	Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years
UCLA Activity score	UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years
SF-12	SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years
EQ-5D	EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.	2 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 201708094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No