Impact of Component Design and Fixation in Total Knee Arthroplasty

November 29, 2021 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in bone density
Time Frame: 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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee society score
Time Frame: 2 years
Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years
Forgotten joint score
Time Frame: 2 years
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years
Oxford knee score
Time Frame: 2 years
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years
UCLA Activity score
Time Frame: 2 years
UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years
SF-12
Time Frame: 2 years
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years
EQ-5D
Time Frame: 2 years
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Nordic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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