Total Joint Arthroplasty in a Pediatric Population

  • STATUS
    Recruiting
  • End date
    Mar 12, 2061
  • participants needed
    1000
  • sponsor
    University of Colorado, Denver
Updated on 12 May 2022

Summary

The primary purpose of this study is to examine the functional ability and quality of life in those patients who received a total joint arthroplasty (TJA) for reasons other than having a solid tumor at the location of the joint.

Description

Patients who undergo a total knee arthroplasty (TKA) or total hip arthroplasty(THA) for non-solid tumor related reasons, are most often those children who developed osteonecrosis or avascular necrosis(AVN) as a side effect of their therapy for leukemia. Other patients undergo TKA or THA after degeneration of their joints secondary to trauma, infection, rheumatologic conditions, or congenital deformity. While not all cases of injury to the knee or hip result in the need for a joint replacement, the quality of life is believed to be improved in these children, as having a functioning joint without pain is believed to be better for the patients' quality of life than ambulating with a painful and/or partially necrotic joint.

Details
Condition Total Joint Arthroplasty
Clinical Study IdentifierNCT04294693
SponsorUniversity of Colorado, Denver
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 10 years and 25 years
Undergoing or have undergone total joint arthroplasty within the past two years from date of approval
Treated at Children's Hospital Colorado by Dr. Nathan Donaldson DO

Exclusion Criteria

Subjects and/or parents not capable of completing basic questionnaires in English (HRQL data will not be collected from non-English speaking subjects because we do not have access to versions of these questionnaires that have been validated in languages other than English. These patients may be included at a later date when validated questionnaires are available)
Subjects who underwent a joint arthroplasty directly related to a tumor at the location of the joint
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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