Memphis, Tennessee 38105


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patient being treated at St. Jude Children's Research Hospital - Diagnosis of osteonecrosis of the hip - Diagnosis of hematologic malignancy or sickle cell disease - Age between 8 and 29 years of age - Patient and/or parent or legal guardian must sign a written informed consent - Patient is considered an acceptable candidate for hip core decompression surgery by his/her primary physician and orthopedic surgeon Exclusion Criteria: - Patient with a diagnosis that is not a hematologic malignancy or sickle cell disease - Patient that has had amputation or reconstructive surgery of the lower extremities - Premorbid condition that prevents patient from ambulating - Patient that has a serious, non-healing wound, ulcer, or bone fracture


NCT ID:

NCT02458937


Primary Contact:

Principal Investigator
Brian M. DeFeo, PT, DPT
St. Jude Children's Research Hospital

Brian M. DeFeo, PT, DPT
Phone: 866-278-5833
Email: referralinfo@stjude.org


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38105
United States

Brian M. DeFeo, PT, DPT
Phone: 866-278-5833
Email: referralinfo@stjude.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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