Impact of Component Design and Fixation in Total Knee Arthroplasty

Completed

• Conditions: Arthroplasties, Knee Replacement
• Interventions: Device: Depuy total knee implant; Device: Triathlon total knee implant

• Registration Number: NCT03272178
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Study Start: 2017-11-20
• Status Verified: 2021-11
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depuy knee total knee arthroplasty	Depuy total knee implant	50 Patients who are assigned to Depuy knee, half cemented/half cementless
Triathlon knee total knee arthroplasty	Triathlon total knee implant	50 Patients who are assigned to Triathlon knee, half cemented/half cementless

Primary Outcome Measures

Name	Time	Method
Change in bone density	2 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States