Osteonecrosis Clinical Trial
Official title:
Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
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.
Hip core decompression (HCD) is not being done as part of this study. Rather, patients who
are undergoing HCD at St. Jude Children's Research Hospital (SJCRH) will be observed for
functional outcomes following the procedure.
HCD is considered an excellent surgical option when considering the multiple issues among
this population, which include young age, the natural progression of osteonecrosis to femoral
head collapse, the limited life expectancy of the prosthetic technology currently available
for total hip arthroplasty (THA), and patient quality of life. This study will seek to
describe functional outcomes and quality of gait following HCD in a pediatric population with
osteonecrosis. The results of this study will provide valuable information as to the
functional limitations within this population pre- and post-operatively.
For each research participant the observations on all outcome measures of interest will be
collected at 5 time points: pre-operatively (baseline measure), and post-operatively at 6
weeks, 12 weeks, 6 months and 1 year. These time points will allow for comparison between
pre- and post-operative outcomes to determine if outcomes are improved following surgery, and
if these outcomes continue to improve over time. This study will also provide a foundation
for the future development of treatment programs designed to target identified limitations
specific to this population.
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