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Total Joint Arthroplasty in a Pediatric Population

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ClinicalTrials.gov Identifier: NCT04294693
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : April 26, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease
Total Joint Arthroplasty

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Total Joint Arthroplasty in a Pediatric Population
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : March 2050
Estimated Study Completion Date : March 2061

Group/Cohort
Pediatric Population
The investigator intends to collect information on all total joint arthroplasty patients identified within the surgical practice of Dr. Nathan Donaldson for non-tumor related diagnoses at Children's Hospital Colorado.



Primary Outcome Measures :
  1. Standard of Care Data (routinely collected in clinic) [ Time Frame: 10 years ]
    Demographic information such as specific diagnoses leading to joint degeneration, age at diagnosis, type of medical treatments leading to need for joint replacement, previous treatments for joint including surgeries, complications, etc.

  2. Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]
    1. Short Form-36 version 2 (SF-36v2)

  3. Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]
    2. Oxford 12 Questionnaire

  4. Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]
    3. Modified Harris Hip Score Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Study Population 1 -- Recent Patients: Subjects that have undergone surgical intervention within the past two years from date of study approval and received a total joint arthroplasty and follow up care with Dr. Nathan Donaldson in the Orthopedics Institute at Children's Hospital Colorado (information about the surgical process and arthroplasty type as well as patient and surgeon reported pain and function will be collected via chart review).
  • Study Population 2 - New Patients: Subjects that are scheduled to undergo a total joint arthroplasty and/or receive follow-up care with Dr. Nathan Donaldson at Children's Hospital Colorado (information about all processes will be collected prospectively via patient interaction and chart review).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294693


Contacts
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Contact: Nathan Rogers 720-777-1905 nathan.rogers@cuanschutz.edu
Contact: Nathan Donaldson nathan.donaldson@ucdenver.edu

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Nathan Rogers    720-777-1905      
Principal Investigator: Nathan Donaldson         
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04294693    
Other Study ID Numbers: 19-0306.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No