Impact of Component Design and Fixation in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthroplasties, Knee Replacement

Intervention / Treatment
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* Device: Depuy total knee implant
* Device: Triathlon total knee implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triathlon knee total knee arthroplasty<br>50 Patients who are assigned to Triathlon knee, half cemented/half cementless | Device: Triathlon total knee implant<br>* patients from Dr Barrack's clinic will get a Triathlon implant<br>|
| Depuy knee total knee arthroplasty<br>50 Patients who are assigned to Depuy knee, half cemented/half cementless | Device: Depuy total knee implant<br>* patients from Dr Nunley's clinic will get a Depuy implant<br>|

What is the study measuring?
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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 |