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Total Joint Arthroplasty in a Pediatric Population

Total Joint Arthroplasty in a Pediatric Population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04294693
Enrollment
1000
Registered
2020-03-04
Start date
2019-06-03
Completion date
2061-03-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Joint Arthroplasty

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.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

Populations 1,2,3 * Age between 10 years and 25 years * Undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons * Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO or Dr. Steven Thorpe, MD or previously by Travis Heare, MD

Exclusion criteria

Populations 1,2,3 * 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 hemiarthroplasties, failed rotationplasty to arthroplasty conversions, or joint arthroplasty directly related to a tumor at the location of the joint * Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism Inclusion Criteria: Population 4 * Age between 10 years and 25 years * Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD or previously by Travis Heare, MD * Symptomatic joint pain treated non-invasively via lifestyle modifications, over the counter or prescription pain medication, nerve blocks or steroid injections, and/or physical therapy * Symptomatic joint pain treated via core decompression surgery at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD, or previously by Travis Heare, MD

Design outcomes

Primary

MeasureTime frameDescription
Standard of Care Data (routinely collected in clinic)10 yearsDemographic 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.
Research Data: Health Related Quality of Life instrument10 years1\. Short Form-36 version 2 (SF-36v2)

Countries

United States

Contacts

CONTACTMia Lundin
mia.lundin@childrenscolorado.org720-777-4871
PRINCIPAL_INVESTIGATORNathan Donaldson, DO

Children's Hospital Colorado

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026