NCT04294693 Total Joint Arthroplasty in a Pediatric Population
| NCT ID | NCT04294693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Total Joint Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-06-03 |
| Primary Completion | 2050-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-06-03 with a primary completion date of 2050-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 Exclusion Criteria: Population 4 * Patients who underwent a joint arthroplasty directly related to a tumor at the location of the joint at Children's Hospital Colorado. Patients undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons * Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism
Contact & Investigator
Nathan Donaldson, DO
PRINCIPAL INVESTIGATOR
Children's Hospital Colorado
Frequently Asked Questions
Who can join the NCT04294693 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 25 Years, studying Total Joint Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04294693 currently recruiting?
Yes, NCT04294693 is actively recruiting participants. Contact the research team at mia.lundin@childrenscolorado.org for enrollment information.
Where is the NCT04294693 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT04294693 clinical trial?
NCT04294693 is sponsored by University of Colorado, Denver. The principal investigator is Nathan Donaldson, DO at Children's Hospital Colorado. The trial plans to enroll 1,000 participants.