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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Research Data: Health Related Quality of Life instrument | 1. Short Form-36 version 2 (SF-36v2) | 10 years |
| Research Data: Health Related Quality of Life instrument | 2. Oxford 12 Questionnaire | 10 years |
| Research Data: Health Related Quality of Life instrument | 3. Modified Harris Hip Score Questionnaire | 10 years |
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Inclusion Criteria: Populations 1,2,3
Exclusion Criteria: Populations 1,2,3
Inclusion Criteria: Population 4
Exclusion Criteria: Population 4
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia Lundin | Contact | 720-777-4871 | mia.lundin@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Nathan Donaldson, DO | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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