Total Joint ArthroplastyNCT04294693
Total Joint Arthroplasty in a Pediatric Population
An observational study of Total Joint Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Total Joint Arthroplasty
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to Mar 2061
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Mia Lundin, 720-777-4871
Nathan Donaldson, DO
About this study
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.
Read the 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.
- Conditions
- Total Joint Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recent Patients | Subjects that have undergone surgical intervention within the past two years from date of study approval and received a total joint arthroplasty and follow up care with Dr. Nathan Donaldson or Dr. Steven Thorpe in the Orthopedics Institute at Children's Hospital Colorado | |
| New Patients | Subjects that are scheduled to undergo a total joint arthroplasty and/or receive follow-up care with Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado | |
| Long-term follow up Patients | Subjects that received a total joint arthroplasty for non-solid tumor malignancies before May 1, 2017 and no longer follow-up in clinic with Dr. Nathan Donaldson | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Research Data: Health Related Quality of Life instrument
- Short Form-36 version 2 (SF-36v2)
Measured: 10 years
Research Data: Health Related Quality of Life instrument
- Oxford 12 Questionnaire
Measured: 10 years
Research Data: Health Related Quality of Life instrument
- Modified Harris Hip Score Questionnaire
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start3 Jun 2019
- Primary completionMar 2050 (estimated)
- Study completionMar 2061 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nathan Donaldson, DO, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294693
- Sponsor's protocol ID
- 19-0306.cc
- Other IDs
- P30CA046934
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2020
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Joint Arthroplasty in a Pediatric Population
- ClinicalTrials.gov ID
- NCT04294693
- Acronym / sponsor ID
- 19-0306.cc
- Conditions
- Total Joint Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- Mar 2050 (estimated)
- Study completion
- Mar 2061 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recent Patients | – | –Subjects that have undergone surgical intervention within the past two years from date of study approval and received a total joint arthroplasty and follow up care with Dr. Nathan Donaldson or Dr. Steven Thorpe in the Orthopedics Institute at Children's Hospital Colorado |
| New Patients | – | –Subjects that are scheduled to undergo a total joint arthroplasty and/or receive follow-up care with Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado |
| Long-term follow up Patients | – | –Subjects that received a total joint arthroplasty for non-solid tumor malignancies before May 1, 2017 and no longer follow-up in clinic with Dr. Nathan Donaldson |
| 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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standard of Care Data (routinely collected in clinic)
Time frame: 10 years
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.
Research Data: Health Related Quality of Life instrument
Time frame: 10 years
1. Short Form-36 version 2 (SF-36v2)
Research Data: Health Related Quality of Life instrument
Time frame: 10 years
2. Oxford 12 Questionnaire
Research Data: Health Related Quality of Life instrument
Time frame: 10 years
3. Modified Harris Hip Score Questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Donaldson, DO principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Joint Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Lundin (720-777-4871, mia.lundin@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard of Care Data (routinely collected in clinic) (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.