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NCT02458937 · ClinicalTrials.gov registry record
Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 17
- Enrollment target
NCT02458937: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT02458937 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02458937 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study Summary
Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in children and adolescents with cancer, particularly among those that have had chronic exposure to glucocorticoids and among those having undergone allogeneic hematopoietic stem cell transplantation. Patients with hematologic disease are also at risk for developing ON. Hip Core Decompression (HCD) is a widely used surgical procedure with several studies reporting positive results; however, most are subject to criticism because of the limited sample size or the absence of appropriate functional outcome measures. The objective of this pilot study is to observe and collect information on several functional outcome measures and assess if Hip Core Decompression (HCD) potentially improves functional outcomes in children, adolescents and young adults with osteonecrosis. PRIMARY OBJECTIVE: * To describe functional outcomes of children, adolescents, and young adults with osteonecrosis of the femoral head following hip core decompression surgery. Parameters assessed will include pain, functional mobility, endurance, quality of life, and gait patterns pre-operatively and post-operatively over time.
Primary Outcome
Pain is measured by using a numeric scale requiring patients to rate any pain experienced in the prior week on a 0 (no pain) to 10 (worst pain imaginable) scale
Interventions
- OTHER Functional Mobility Assessment
- OTHER GAITRite® System
- OTHER Range of Motion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-06-05 |
| Est. Completion | 2018-09-26 |
What the finished NCT02458937 record still lists
NCT02458937 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Functional Mobility Assessment is the first listed.
NCT02458937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02458937 about?
NCT02458937 is a clinical study titled "Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis". Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in children and adolescents with cancer, particularly among those that have had chronic exposure to glucocorticoids and among those having undergone allogeneic hematopoietic stem cell transplantation. Patients wit...
What is the current status of trial NCT02458937?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2015-06-05. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT02458937?
The interventions under investigation include: Functional Mobility Assessment (OTHER), GAITRite® System (OTHER), Range of Motion (OTHER).
Who is sponsoring clinical trial NCT02458937?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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