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Completed

NCT Number: NCT03272178

Impact of Component Design and Fixation in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Depuy total knee implant

Device

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

Triathlon total knee implant

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. knee society score

    Time frame: 2 years

    Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

  2. Forgotten joint score

    Time frame: 2 years

    Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

  3. Oxford knee score

    Time frame: 2 years

    Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

  4. UCLA Activity score

    Time frame: 2 years

    UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

  5. SF-12

    Time frame: 2 years

    SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

  6. EQ-5D

    Time frame: 2 years

    EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2017
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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