Total Joint Arthroplasty in a Pediatric Population

Recruiting

• Conditions: Total Joint Arthroplasty

• Registration Number: NCT04294693
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-06-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2050-03
• Study Completion: 2061-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Research Data: Health Related Quality of Life instrument	10 years	3. Modified Harris Hip Score Questionnaire
Standard of Care Data (routinely collected in clinic)	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States