Total Joint Arthroplasty in a Pediatric Population
ConditionTotal Joint Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-25
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Age between 10 years and 25 years
Trial population
* Study Population 1. Recent Patients: Subjects that have undergone surgical intervention within the past 2 years from date of study approval \& received a total joint arthroplasty \& follow up care with Dr. Nathan Donaldson or Dr. Steven Thorpe in the Orthopedics Institute at Children's Hospital Colorado . * Study Population 2. New Patients: Subjects that are scheduled to undergo a total joint arthroplasty \&/or receive follow-up care with Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado . * Study Population 3. Long-term follow up Patients: Subjects that received a total joint arthroplasty for non-solid tumor malignancies before 05/01/2017 \& no longer follow-up in clinic with Dr. Nathan Donaldson. * Study Population 4. Control group Patients: Subjects with a clinical relationship to Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado to act as a control group for statistical matching of the above populations.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 4 trial groupsGroup A: Recent Patients
Group B: New Patients
Group C: Long-term follow up Patients
Group D: Control Group Patients
Trial outcomes
Primary outcomes
1
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.
Time frame
10 years2
Research Data: Health Related Quality of Life instrument
1\. Short Form-36 version 2 (SF-36v2)
Time frame
10 years3
Research Data: Health Related Quality of Life instrument
2\. Oxford 12 Questionnaire
Time frame
10 years4
Research Data: Health Related Quality of Life instrument
3\. Modified Harris Hip Score Questionnaire
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov