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Impact of Component Design and Fixation in Total Knee Arthroplasty

NCT ID: NCT03272178

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2021-11-15

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.

Conditions

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Arthroplasties, Knee Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Triathlon knee total knee arthroplasty

50 Patients who are assigned to Triathlon knee, half cemented/half cementless

Triathlon total knee implant

Intervention Type DEVICE

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

Depuy total knee implant

Intervention Type DEVICE

patients from Dr Nunley's clinic will get a Depuy implant

Interventions

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Depuy total knee implant

patients from Dr Nunley's clinic will get a Depuy implant

Intervention Type DEVICE

Triathlon total knee implant

patients from Dr Barrack's clinic will get a Triathlon implant

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Nordic

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201708094

Identifier Type: -

Identifier Source: org_study_id