Total Joint Arthroplasty in a Pediatric Population

Total Joint Arthroplasty Clinical Trial

Official title:

Total Joint Arthroplasty in a Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294693
• Other study ID #: 19-0306.cc
• Secondary ID: P30CA046934
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Total Joint Arthroplasty

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