Evaluating joint replacement outcomes in children
Total Joint Arthroplasty in a Pediatric Population
University of Colorado, Denver · NCT04294693
This study is trying to see how total joint replacement surgeries affect the pain and mobility of children aged 10 to 25 who have had these surgeries for reasons like leukemia treatment or congenital issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 10 Years to 25 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04294693 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing the functional ability and quality of life in pediatric patients who have undergone total joint arthroplasty (TJA) for non-solid tumor related reasons. It specifically targets children aged 10 to 25 years who have received total knee or hip arthroplasties due to conditions such as osteonecrosis or avascular necrosis resulting from leukemia treatment, trauma, or congenital deformities. The study aims to gather data on how these surgeries impact the patients' quality of life, particularly in terms of pain relief and mobility. The research is conducted at Children's Hospital Colorado under the guidance of experienced orthopedic specialists.
Who should consider this trial
Good fit: Ideal candidates are children aged 10 to 25 years who have undergone total joint arthroplasty for non-solid tumor related reasons at Children's Hospital Colorado.
Not a fit: Patients who have undergone joint arthroplasties related to tumors or those with specific genetic disorders like mucopolysaccharidoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving the quality of life for pediatric patients undergoing joint replacements.
How similar studies have performed: While there is limited data on similar studies specifically in the pediatric population, existing research on joint arthroplasty outcomes in adults has shown positive results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Nathan Donaldson, DO — Children's Hospital Colorado
- Study coordinator: Mia Lundin
- Email: mia.lundin@childrenscolorado.org
- Phone: 720-777-4871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Joint Arthroplasty