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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04294693
Other study ID # 19-0306.cc
Secondary ID P30CA046934
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2019
Est. completion date March 2061

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact Nathan Rogers
Phone 720-777-1905
Email nathan.rogers@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date March 2061
Est. primary completion date March 2050
Accepts healthy volunteers No
Gender All
Age group 10 Years to 25 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard of Care Data (routinely collected in clinic) 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. 10 years
Primary Research Data: Health Related Quality of Life instrument 1. Short Form-36 version 2 (SF-36v2) 10 years
Primary Research Data: Health Related Quality of Life instrument 2. Oxford 12 Questionnaire 10 years
Primary Research Data: Health Related Quality of Life instrument 3. Modified Harris Hip Score Questionnaire 10 years
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